chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient vaccinated without incident.  Wife of patient phoned pharmacy at approximately 10:00am this morning reporting that her husband (patient) was having numbness and weakness in both legs, not allowing him to bear weight.  Patient conscious and breathing normally.  I advised her to immediately call EMS for evaluation.
Case number PHEH2014US005904, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 15-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degree Celsius) for up to 24 hours on 16 Jan 2014. No adverse even was reported following the maladministration.
3:30 shot received. 4:00 tongue numb, tingling in mouth. 4:25pm 50mg Benadryl. 4:29pm 200/100mmHg. 4:25pm pulse 108bpm 98%sp02. 4:35pm 230/104mmHg, 116bpm, 98%sp02. 4:40pm slight trouble breathing, 98%sp02, 105bpm. 4:43pm 240/150mmHg. 4:44pm 230/130mmHg.
After approx 3 hours, chills, overnight began severe muscle aches and joint pains, often stabbing pain, low grade fever. To descibe as flu-like symptoms is way to mild, this was awful for  about 60 hours, then stopped.  I could not work for 2 days and was in bed.
Patient reports having a nose bleed that lasted appox. 20 minutes about an hour after getting the booster dose of Janssen.
Patient states feeling light headed. BP taken at 11:57 am 139/100 given bottle of water monitored. 12:02 136/103, 12:12 am BP 140/104 advised patient relax and stop talking on the phone. 12:18 pm 136/103 am given bottle of Gatorade: stated slight dizziness, 12:28 pm BP 135/96, HR 72, 12:40 pm 130/99, HR 72, 12:54 pm 118/95, 1:30 pm BP 126/97. Patient states feeling a little tired dizziness has lessened. No other symptoms voiced or noted. Color is good. Patient ambulated to car with out any S/S of distress. Advised to call 911 if SOB, light headed, dizziness, chest palpitations or BP goes exceeds 100 diastolic., RN
Lot number has a manufacturer expiration date of 10/14/2021. It was placed in the refridgerator to thaw on 9/16/21 at 8:30am. The vial was first opened and one dose given to patient on 10/15/2021 at 8:00am. It was immediately noted that this vaccine was past manufacturer expiry date. The patient was notified. Moderna was immediately contacted. This form filled out.
Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22; doses given after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Bactrim).    On 19-Jul-2022 at 12:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jul-2022 at 12:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.      Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Follow up  received contains significant information: Updated report type from invalid case to spontaneous (received patient details in follow up). Added patient's details, medical history, suspect details and start date of event.; Sender's Comments:
pt recv vax & exp wild type chickenpox about 12 to 10 days PTA;now w/afeb pox illness face-trunk-1-red papules vesicles & early pustules;dx atypical chickenpox;pt exp rash on face;+pruritic;
Patient sweated, skin color was changed to very pale white color, and  passed out, but regained consciousness.  We checked his vitals (118/79, 57) and called 911.  Paramedics came and checked on him, but pt passed out again after he was asked to stand up.  His blood pressure dropped very low and heart stopped for about 10 seconds.  Therefore, he was taken to hospital.
Date/time of event reported by patient: 02/23/21, 09:00AM, patient reports to healthcare center and reports "gradual psychotic episode" one week following vaccine administration; denies effects today.  03/23/21 11:15AM:  Phone communication with RN: Patient is at home, stable, in no distress. Patient reports after receiving his first dose of the Moderna vaccine, he shortly started noticing "gradual psychoactive effects," that he describes as "it just drove me mad." Patient reports "effects wore off now." Denies concerns/effects today.
Patient stated the next day she had severe redness in her arm that was vaccinated.  It continued to spread down so her provider so he gave her an antibiotic shot and then prescribed on 11/23/21 cephalexin 1000mg twice daily for 10 days.  Then a prednisone 40mg daily for 5 days on 11/30/21.  Then on 12/10/21 he did another dose of cephalexin 1000mg twice daily for 10 days.  She said her provider said she was lucky to keep her arm.  Prior to administration we always alcohol swab the area and wait for it to dry.   She said it was cellulitis.
A week after second vaccine I had stomach pains, headache, nausea, vomiting, loss of appetite
Head ache; sweaty; Got into elevator to go back to work and passed out. Assessed by physicians assistant and was released, sent home for the day.
immediately after the immunization every muscle in my body severely hurt. Within an hour of the immunization, I had sudden extreme  exhaustion and fatigue  to the point I feel asleep while eating and I had nausea, vomiting, diarrhea, stomach cramps and 103 degree fever. My skin also turned pink all over my body. I am still this many days out in extreme pain. All my muscle in my body hurt severely to the point my muscle pain wakes me up from sleeping. Last night I was again awaken from all of my muscles hurting. The pain was so bad that I felt I needed to an ER for pain control. The only reason that I did not go to an ER is because I do not live close to an ER. I am I so much pain and have so many GI symptoms and such bad fatigue that I do not feel that I can drive to my nearest ER which is far away from me. I considered calling for an ambulance but I was not sure if this is the type of thing you call an ambulance  for since I was not having an life threatening issue. I was not sick prior to this immunization. In fact, I have a berry healthy lifestyle and diet and I was feeling very well prior to this immunization.  Now that it is amiss business hours, I am going to see if I can get someone to drive me to the doctor today. I normally can drive but I have been too sick to drive since this immunization.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # M020521, expiration date 17-NOV-2017, intramuscular, dose not specified) for prophylaxis. "The next day" (date not specified), the patient was seen at the pharmacy, complaining of "redness, swelling, pain, and inflammation". The pharmacist recommended the patient to take TYLENOL and use an ice pack. No lab diagnostics studies were performed. The patient was recovered on an unknown date. The pharmacist requested a lot check for this lot of PNEUMOVAX 23. This is one of three reports received from the same source involving same events and same lot #. Additional information has been requested. Sender's Comments: US-009507513-1701USA003778: US-009507513-1701USA003855.
SWELLING IN LEFT SHOULDER; INCREASED PAIN IN LEFT SHOULDER; TWO TENDONS RUPTURED ON LEFT HAND; This spontaneous case was reported by a consumer and describes the occurrence of TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND), JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In April 2022, the patient experienced TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND). On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER). At the time of the report, TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND) was resolving and JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Tendon rupture, Joint swelling, Arthralgia aggravated was assessed as "Not reported" for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Patient was given pfizer dose for children age 12 and over when patient age is only 10.  Patient should have been given product with the orange cap but instead was given product with the gray cap.  A voicemail has been left with the patient.
headache, body aches (shooting pains in ear, lower back, top of head), low grade fever (100.0) for 3-4 hours, fatigue
This spontaneous report as received from a Registered Nurse (RN) who refers to a male patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis. Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011874.
no adverse effect reported; 22 year old patient received one dose of PROQUAD; This spontaneous report was received from a healthcare professional (Medical assistant) refers to a 22-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On 22-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), via subcutaneous route for prophylaxis (Therapy type: rHA, Lot # S006830, expiry date: 02-SEP-2020). Other suspect therapies included sterile diluent (STERILE DILUENT) (Lot # S013899, expiry date: 07-MAR-2022). On 22-AUG-2019, the 22-year-old patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age). No adverse effect reported. No PQC involved. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.  This is one of the two report received from the same reporter.
Dtap/ipv portion was administered without reconstituting with the HIB portion/no AE; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (unknown demography) who had received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which DTAP/IPV portion was administered without reconstituting with the HIB portion (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
This case was reported by a physician via other manufacturer and described the occurrence of headache in a adult patient who received dTpa vaccine. Co-suspect products included Influenza vaccine and PREVENAR 13. On an unknown date, the patient received dTpa vaccine at an unknown dose, Influenza vaccine at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, an unknown time after receiving dTpa vaccine and Influenza vaccine, the patient experienced headache and joint pain. On an unknown date, the outcome of the headache and joint pain were unknown. It was unknown if the reporter considered the headache and joint pain to be related to dTpa vaccine and Influenza vaccine. Additional details were provided as follows: The patient's age at vaccination was not reported. This patient had been vaccinated with Influenza and Tdap vaccines as well as PREVENAR 13 at the same time. The reporter informed that, one adult patient came complaining from headache and joint pain after receiving the PREVENAR 13. She wanted to know how long this side effect will last and if there was any further complication expected.
This case was reported by a nurse and described the occurrence of cellulitis of leg in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. There were no concurrent medications. On 23Feb06 at 2:08PM, the subject received a dose of Pediarix in the left thigh (lot AC21B051AA). The nurse reported that this was the 1st dose of Pediarix, but this was the 5th dose in the diphtheria and tetanus toxoids and acellular pertussis vaccination series. Pediarix is only recommended for the first three doses in the diphtheria and tetanus toxoids and acellular pertussis vaccination series. On 24Feb06, in the morning, approx 1 day after vaccination with Pediarix, the subject experienced cellulitis of the leg, large wheal and erythema of leg, and swelling of the leg. The subject was seen at a physician's office and was treated with antibiotics. The events resolved on 25Feb06. The nurse considered the events to possibly be related to vaccination with Pediarix.
Information has been received from a registered nurse concerning a 5 year old white female with a history of asthma who on 07FEB2000 was vaccinated in the "RQ" with a second dose of varicella virus vaccine live. There was no illness at the time of vaccination. ON 18DEC2003 the patient presented to the office with a red raised rash on her back, chest, face and eyes. It was noted that her brother had shingles three weeks ago. The patient was diagnosed with chickenpox. The patient was sent to an eye doctor due to pox in the eye. No diagnostic laboratory tests were performed. Subsequently, the patient recovered (date of recovery was not available). No further information is expected.
9/23 @ 8:52  ptr called saying had vaccines given in R arm Tue & arm is very swollen, very painful & red.  Also has H/A & feels general malaise.  Denies fever.  Site not itchy, not scratching her skin.  Informed that sx should start declining.  Use ice pack to area about 15 min 3X/day.  Can use OTC pain med.  Seeing will be moving out of town this Tue, to come in our walk-in hours from 4-7.  She stated understanding & plans to come in after 4 pm. 9/26 @ 3:28  pt returned call and said her arm is much less painful, not as red or hot, and swelling is down,  She said when mentioned you didn't come to our after hours, "I'm a tough girl so I toughed it out."  Did do cold packs and take Advil.  Moving tomorrow (9/27/16).
ACHES; SWEATS; SICKNESS; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sweats, sickness, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, sweats, chills, fever, fatigue and sickness was not reported. This report was non-serious.
Around 4 pm I was starting to feel a little sore. By 4:30 pm I had some major chills that turned into hot flashes. At around 4:30 pm I took 400mg of Ibuprofen. For 1 hour I was fighting a fever and chill spells that rapidly changed during that 1 hour time period, ending at 5:30 pm. Within that time I had major acks in my back and neck. I also experience sinus pressure and pins and needs in my ears and behind my ears. After 5:30 pm I did feel significantly better and now are 8:00 pm I feel exhausted, my head hurts and my ears feel like they weigh a pound each. Hope that was helpful. Thanks for doing what you're doing.
I received both the Influenza and Pneumococcal vacines at the same time on Sat 11/08/2008 at 2:00PM at a store. By Sun 11/09/2008 at 2:00AM I was experiencing an adverse reaction to the vaccine administer in my right arm, I believe that was the pneumococcal vaccine. My right arm was very sore, I had a fever, shortness of breath, weak, unsteady walking, headache. After breakfast on 11/09 at 9:00AM, I lost conciousness and collapsed to the floor. On 11/09 at 11:00AM, I again lost conciosness and collapsed on to the floor injuring cutting my forehead, eye brow, and eye lid. I bruised my right thumb severely, right knee, and left shoulder were injured.
Chest pain intermittent for two days Shortness of breath continuous for about a week Fatigue for about a week Fever of 100-102 for 3 days Muscle/body aches for 3 days Headache for 4 days
R) band 4cm from med to lat leg-red/warm. L) area 1.5cm in diameter-red/warm. MD visualized red reaction on bilateral legs/thigh at IM site.
Patient reported dizziness following vaccination while in observation station.  Patient was advised to lay supine. Also given water/snack. BP 11:23am: 116/84, Pulse: 92.  Last meal/snack/drink: 11 hours prior No history of Allergies Symptoms resolved after hydration/food/rest.
Pt tolerated procedure well, but unfortunately was not due for MENACTRA. MMR was intended to have been given instead of MENACTRA. This was also given via SC injection.
Approximately  5 months after my second dose shot, I began to experience intestinal cramping and diarrhea.  By the 2nd day, I notice blood in my stool, intense pain and cramping.  I was given a CT scan and diagnosed with "pan colitis".  I was given pain medication, IV fluids and a restricted diet.  Cultures revealed no bacterial cause and I was discharged from the hospital.,
I had chills, fever, body ache, and weakness. These lasted for about 4 days. On Jan 1 I tested positive for covid-19.
employee states hours after the infection while she was at home she began having severe chills, dyspnea, pain in legs, dizziness, and difficulty walking. She says she was not able to sleep because of the chills and shaking. Several hours after the chills subsided but she says it was still difficult to walk. She was able to work that night, because by the time she got up she was able to function. She says she received the pneumonia shot week prior. She received no TX.
I had chest pain on the right side of my chest between my rib cage and below my shoulder. I went to an immediate care facility. They did a bunch of tests. They diagnosed it as a blood clot pulmonary embolism. I was sent to the ER and they did a scan. They confirmed the diagnosis. They put me on a blood thinner called Eliquis. I was in the hospital for one day.
I was having a headache on that Monday and a sensation in my ears like equilibrium was off. I then developed a cough. I took a COVID-19 test on that Tuesday and that was negative. I tested two days later and tested again on the 26th and that test was positive. Between those two tests I developed a severe sore throat and had body aches along with a light grade fever. I called my PCP and they gave me PAXLOVID to help with my symptoms which I took and began feeling better right away. I ended up testing again on Monday the 30th and that COVID-19 test showed I was still positive. I then waited two days and was negative on that Wednesday when I tested.
This spontaneous report was received from a medical assistant concerning to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates since 02-MAR-2017, the patients were vaccinated with improperly-stored doses of ROTATEQ lot # M032636, the expiration date: 06-APR-2018 and lot#  M038728, the expiration date: 25-APR-2018 (dose a route were not reported) for prophylaxis. There was no concomitant medication provided.  No adverse effects have been reported. The call was made due the data logger.The temperature of excursion was between 32°F to 35°F during 1 hour and 15 minutes. There was no previous temperature excursion provided. Additional information has been requested.
Information has been received from a registered nurse concerning a male who on an unspecified date was vaccinated subcutaneously with a dose of Zostavax. Subsequently the patient developed zoster three days after vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not expected.