chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore at the injection site pain that goes down from bicep above elbow and down to wrist; arm feels weak when he moves it in certain ways; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and weakness of arms. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and weakness of arms to be related to Shingrix.  Additional details were provided as follows: In mid of May 2019, the patient received Shingrix in an unknown arm. The patient's arm was sore for 3 days afterwards at the injection site, but then he started experiencing pain that went down from his bicep above his elbow and down to his wrist. The patient was still experiencing that pain and his arm felt weak when he moved it in certain ways.
Myalgia, Arthralgia and muscle/joint pain in shoulders/hips/knees.
pt recvd vax & went to urgent care w/fever of 103, flu-like sx; arm was not giving much trouble; pt recovered w/no sequelae-addtl pt has never recvd a pneumococcal vax;
pneumonia; had pneumonia after having Prevnar 13; Inappropriate dose of vaccine administered; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer reported for herself.  This 93-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose for pneumonia shot. She received her first Prevnar 13 in 2013 and a second Prevnar 13 in 2015. Medical history included that she had scarred lungs as a teen and when she gets a cold it goes to her chest. Concomitant medications were not reported. On an unspecified date in Nov2017, the patient had pneumonia after having Prevnar 13 with outcome of unknown.  The information on the lot number has been requested.
not feeling well; cough; runny nose; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on 17Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her first dose, and second dose is due tomorrow, 08May2021. However, from unspecified date the patient is not feeling well, had a bad cough and runny nose and her doctor told her that she should not get the second dose of the vaccine tomorrow. The Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hours after the following immunizations, DPAT, HIB, Prevnar, the baby had 2-3 hours of inconsolable crying. For the next days, he was more irritable than usual, wouldn't play and needed to be held when awake. His physical exam was normal 6 days after the immunizations.
I felt completely fine after my vaccination, aside from nerves and a sore arm , until around 7:30 that night. After I ate dinner I was hit with a wave a nausea that lasted until I vomited then went away. Also, almost 24 hours to the minute my arm (which was really sore) instantly felt better.
Spoke to pt on phone states she is having severe pain at vaccination site x3d. Denies redness or swelling. As pt is now on travel, advised her to be seen locally. Pt agreeable.
pt recv 2 doses of vax & approx JAN98 lab eval revealed that varicella titers were negative;
Presents for SOB x3 days. Admit for acute respiratory failure w/hypoxia 2/2 COVID pneumonia. DNR, requested to stay on BiPAP (unable to wean down). Placed on comfort measures per family request, expired on hospital day 10. Tx: O2 via BiPAP, remdesivir, dexamethasone, abx, baricitinib.
I have red bumps popping up on arms, torso and legs; typical redness by the injection site; started to have these itchy bumps on the arms and progressing down from there; It is like it is progressing through my body from head to toe; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had red bumps popping up on arms, torso and legs. Predominantly legs and arms. This started after 2nd Covid shot. Initially typical redness by the injection site, then started to had these itchy bumps on the arms and progressing down from there, it was like it was progressing through body from head to toe (condition aggravated). It was reported that now 17 days out and was still getting more annoying. Patient did not have this reaction after the first injection. Outcome of all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient experienced full body rash within 24 hours and strange bruise-like spots about 4 days after vaccination
At around 12 pm the day after my immunization, I felt very tired, a little chilled, achy, mild head ache, and had very little appetite.  This lasted throughout the rest of the day.  I woke up the following morning feeling fine.
not feeling well; This is a spontaneous report based on the information reported to Pfizer (Reference ID: NVSC2021US087521). This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for covid-19 Immunisation. The following information was reported: MALAISE (non-serious) with onset 29Apr2021, outcome "unknown", described as "not feeling well".  Additional information: Patient stated she got her 2nd COVID vaccine and She was not feeling well today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported arm swelling, pain and redness down to her left elbow. Self treated initially with Aleve. Pharmacist recommended ice, Tylenol and Benadryl. If symptoms worsen, to contact PCP. She did report to Dr following day, who asked her to stay on treatment recommended, and come to office if her symptoms worsen. After 6 days her arm has stabilized, symptoms improved, with minimal swelling, pain and redness.
Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a dose of Gardasil (yeast). On 27-JAN-2007 the patient developed a rash on her arm, chest and back. The patient sought unspecified medical attention. Additional information has been requested.
Headache immediately following vaccine administration. Symptoms initially improved then returned. Patient reports 3 weeks of headache. Labs demonstrated elevation in AST/ALT
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
Pt received Flu shot with no issue. She mentioned she needed a pneumonia shot, looked in her profile and she received PREVNAR 13 in April 2017. Did paperwork and few minutes later administered PNEUMOVAX. Pt stood up and was ok. She started walking away from the immunization area and sat down. My techs alerted me that her caretaker/family member said she was dizzy and couldn't breathe. I start talking to the patient and caretaker asking if she was ok and said she couldn't breathe. Was wheezing, SOB, face/lips turning blue/purple. Called 911, went back to the waiting room, gave her some water. Administered epinephrine 0.3 mg pen (expired May 2018), left thigh IM. Her face, had color and her breathing improved. Paramedics arrived rather quickly after 911 call (maybe 5 minutes?). They took over the scene, told them what happened and summary of events. She was given a breathing treatment and was then transported to the ER. Have not heard any follow up. She was in good spirits and was feeling better.
Pt vacc. /w Mumpsvax 1st dose in response to local mumps epidemic, 2 wks later he developed chest pain & abnormal ECG. Admitt to hospital & died 2 days later /p admission /w DX of myocarditis.MD could not establish a causal relationship.
Moderate to severe pain in left shoulder around injection site (8? circumference) started at 4 hrs post injection.  Day 2 (8 am) immediate chills, shaking, joint & muscle pain in hips and legs, weakness, out of breath easily (walking to leave work).  Day 2 (10 am fever of 99) chills, weakness. Fever of 101 -Tylenol helped.  Day 3 Continued with same, but less severe symptoms through Day 3. Some relief of fever and arm pain with Ibuprofen or Tylenol.
1/27/21:  Dizziness - very strong about 30 hours post vaccine and then again about 31 hours post vaccine.  Very likely to fall if I wasn't able to sit/lay right down. 1/28/21:  Dizziness - less severe than previous day but still had to lay down, occurred twice in the morning after getting out of bed at approximately 8 am  1/29/21:  Dizziness - much less severe and it came and went, however if I moved my head too fast it would happen  1/30/21:  Periodically vaguely dizzy
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 67 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Pain, redness and swelling site of injection at left arm extending to elbow. PO antibiotic Augmentin Solumedrol 125 mg and Rocephen 1 gm.
This spontaneous prospective pregnancy report as received from a physician refers to a 38 year old female patient. The patient pertinent medical history included asthma. On 12-SEP-2016 the patient was inadvertently vaccinated with GARDASIL 9 lot # M007764 who was 29 weeks pregnant. Concomitant therapies included PULMICORT, fluticasone, albuterol and unspecified prenatal vitamins. The patient became pregnant with LMP of 22-FEB-2016 and EDD of 28-NOV-2016. Initial exposure to GARDASIL 9 was at 29 week(s) (Exposure during pregnancy). On 12-SEP-2016, 1 day after onset of therapy the patient experienced soreness at the injection site. The patient sought medical attention. The patient did not receive any treatment for the event. The outcome of soreness at injection site was unknown. The outcome of pregnancy was unknown. The reporter did not provide the causality between the event soreness at the injection site and the suspect therapy. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of urticaria generalized in a 44-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). This case was associated with a product complaint. Previously administered products included Flu vaccine (the patient did not experience any adverse event after Flu vaccination). On 29th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 29th September 2016, 10 min after receiving FLULAVAL QUADRIVALENT, the patient experienced urticaria generalized and formication. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the urticaria generalized, formication and pharmaceutical product complaint were unknown. The reporter considered the urticaria generalized and formication to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by a registered nurse. The patient experienced urticaria which was present all over her body but began behind the patient's knees and back, then spread and formication after vaccination with FLULAVAL QUADRIVALENT on left deltoid. The reporter stated that a multidose vial of FLULAVAL might be suspect. It caused various adverse drug events in several patients with similar adverse drug event pattern. The suspect vial was available for return. Replacement or credit was not requested by reporter. This case is 1 of the 3 cases reported by the same reporter.
Patient reports numbness and tingling to tongue followed by bilateral sides of face. Symptoms to tongue and left side of face are now resolved (approx. 1 hour following vaccination)
Reporting a vaccine administration error.  Patient was given a dose of Moderna vaccine that was expired at the time of administration.  Vial that dose was drawn from was moved from freezer to fridge on 8/30/2021 at 8:45pm, starting a 30 day expiration per manufacturer.   Error was discovered on 10/5/2021 after a subsequent vial from the same box was identified as being expired.  Manufacturer was contacted on 10/6/2021  for guidance.  Manufacturer indicated on 10/6/2021 that they will "conduct an analysis to determine if the vaccine administered past 30 days provided the necessary protection against a COVID-19 infection".  Attempted to contact patient on 10/6/2021, and left voicemail for patient to call back to discuss error.
Pain, swelling and redness in large area of upper arm began several hours after vaccination. Next day, pain made it difficult to move or use right arm, particularly difficult to raise arm. Headache. Now almost 48 hours since vaccination, swelling, redness and pain have subsided. Headache better with aspirin.
Fever X 5 days, then a rash which spread and resolved by day 7.
About 10 minutes after receiving vaccine, I experienced a gurgling sensation on the left side of the chest while breathing. That lasted for about 5 minutes and then dissipated. Throughout the day, I had intermittent chest pain. Upon going to bed that night I found I could not sleep on my right side because it hurt to breathe (primarily to exhale). On my back, I was okay. I had minor chest pain, all on the left side, the next day (3/18)  in the morning. By lunchtime it was gone. The evening of 3/18 (roughly 5:15-7:00), I experienced extreme chills. Finally put on my winter coat over my sweatshirt to get warm.
Administered 12 year + dose to patient instead of correct dose (5-11 year). Mistakenly drew up the incorrect vial. Caught the mistake when charting the vaccination.  No known adverse reaction at this time.
Headaches everyday, muscle pain, lethargy, brain fog, vomiting and overall generally feeling poor for 9 days
chills; fever of 98.9 F; bodyaches; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 98.9 F), MYALGIA (bodyaches), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Diabetes mellitus.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 98.9 F), MYALGIA (bodyaches), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, CHILLS (chills), PYREXIA (fever of 98.9 F), MYALGIA (bodyaches), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt has immediate reaction - redness and soreness, within a day the area was as big as a baseball, had a huge bruise, warm to touch and was hurting.
Fever 105 Degrees F, Bloody Nose, Rash on chest, Currently day 3 and pt is still suffering from all of the above listed symptoms.
Lethargy immediately after giving immunizations; lasted x 4 days, fever to 103 one time on fourth day following immunizations; evaluation in my office on fifth day following immunizations, patient appeared well, otherwise asymptomatic.
Patient received booster Pfizer vaccine in left arm.  She now has swelling in left arm and surrounding area of chest.  I suggested she have it looked at by doctor.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP. HCP requested the list of information necessary for an assessment to be sent to her email since she did not have the info available at the time of the call and she would contact us again with that information. This case is for patient 61 out of 100 patients. Concomitant medications were not reported.  No treatment information was provided   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
SITE BECAME FIRM, RED, HOT TO TOUCH. LOW GRADE TEMPERATURE AT 100.5 DEGREES F REDDENED AREAS ON FOREARM
Two days (so far) of Severe Malaise, Chills, Muscle Aches, Headache, Sleepiness, Sore Arm, Back Pain, One short episode of nausea
injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain; injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain; Initial information received on 18-Oct-2019 and additional information received on 21-Oct-2019, regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 71 years old female patient who developed injection site reaction described as redness, the redness on area was about 3 inches long and 2 inches wide and having pain (inflammation and vaccination site reaction), while she received vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) in left arm for Immunisation.  On 14-Oct-2019, the patient received a dose (0.5 mL) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ268AB, expiry date: Jun-2020) via intramuscular route in the right arm. On 14-Oct-2019, the patient received a dose of suspect PNEUMOVAX not produced by Sanofi Pasteur (lot S018140, expiry date: 30-Jun-2020) via intramuscular route in the right arm.  On an unknown date, the patient developed a non-serious injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain (inflammation and vaccination site reaction), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX.  Other relevant tests were not reported.  Final diagnosis was inflammation and vaccination site reaction.  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.
Deep Vein Thrombosis left calf 3 cm. , Eliquis 2x/day, outcome unknown as treatment just started
The day after the first vaccine dose, I had severe neck pain.  Sometime (a week or two?) after the second dose I had severe left knee pain. Within a week or two of the third dose I had a gradual onset of shoulder pain
On the evening of the 27th had a sore throat which lasted a few days.  Took BetaCarotene and Grapeseed Extract to counteract.   Later in evening started sneezing and runny nose lasting a few days.  On day 3 had horrible bronchial type cough lasting a few days which really hurt when coughing.