chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bedtime Friday 10PM 10/10 with sore arm. Woke up at midnight-1AM with swollen lips, whelps around groin area/armpits. Both upper arms, waist. 10/11 took BENADRYL 2 tabs (25 mg) and went back to bed. Up at 6:30AM , went for a walk stop to rest, hives had decreased with med q 4-6 hours. 10/13/08- body aches fever-none.
Expired vaccine was in freezer until the evening before the administration date; Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Expired vaccine was in freezer until the evening before the administration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was in freezer until the evening before the administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Expired vaccine was in freezer until the evening before the administration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Provider stated that the vaccine was in freezer until the evening before the administration dates provided. Expiration Date was on 09-Nov-2021. No treatment medications were reported.
pt recvd MMR vax on 20MAR89 & approx 3 months following vax pt devel polyneuritis & was sen to a med ctr; dx w/GBS & hospitalized; MD stated neighter he nor the other MD who examined pt believed exp was related to vax;
11/06/2008 received FluMist at Flu Clinic/Exercise.  11/11/08-noticed slight rash on rt. side of upper lip, during weekend spread to outer left side of nostril. MOC took child to clinic on 11/17/08, rash dx. as staph infection (impetigo) given medication and instructions to stop spread, also told to report it to Public Health.
Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A87163B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread). At the time of the report, RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread) had not resolved.            No concomitant medications were reported.  On 10-Feb-2021, the patient received the first dose of Moderna COVID-19 vaccine (Lot number: 031L20A). On 11-Mar-2021, the patient received the second dose of Moderna COVID-19 vaccine (Lot number: 048A21A). On 21-Oct-2021, the patient received the first booster dose of Moderna COVID-19 vaccine (Lot number: 026O21A). On 04-Apr-2022, the patient received the second booster dose of Moderna COVID-19 vaccine (Lot number: 002M21A).  The patient had not seen a physician and had not reported this effect to her physician. The rash was persisting 2 days after administration of bivalent booster dose.  No treatment medications were reported.
This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions and allergies were not provided. On 24-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 for prophylaxis (lot# N003997, expiry date: 20-OCT-2018, dose unknown). No concomitant medications were reported. No adverse effects were reported. The excursion information was as follows: Temperature: 35.8F Time frame: 30 minutes. No previous temperature excursion. Call was because of "digital data logger": Yes.
my arm swelled up; my arm swelled up and hurts in it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my arm swelled up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm swelled up and hurts in it".  Additional information: Caller stated he/she had that Covid-19 (vaccine) on his/her arm, his/her arm swelled up and hurts in it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022; Initial information received on 08-Mar-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 16 years old female patient who experienced has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022 while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of o.5 ml with lot U6878BA via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious "has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022 (expired product administered)" (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that "Practice manager is calling to ask information about MENACTRA that has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022).  At time of reporting, the outcome was Unknown for the event has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022.  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.
Morbilliform rash that started about 12 hours, post vax of the 3rd dose of Prevnar. The child had preceding fever and pulling at ear X 2 days prior to vaccine. Child well with rash.
Initial side effect of significant swelling to affected arm and hand, resolving by morning. 24 hours post injection, awoke with headache comparable to having been hit in head with baseball bat (this continues to be ongoing 3 weeks later). Fever of 100.4, resolved after 1 day. Nausea, increased blood glucose. Continued fatigue and muscle pain/weakness. Following day my scalp, upper back/shoulder blades down arms to finger tips were burning as though I was on fire. This has been relentless. Beginning the second week, it has spread to my ears, several inches down my torso and includes the front of my body as well. Extremely sensitive to touch, including clothing and increased temperature (standing next to someone/ walking outside). There is immense pressure/pain that comes and goes in all of these areas as though they are in a vice. It is at its worst in the evening and first thing in the morning depending on how I slept (ie: if I lay on my stomach, my entire abdomen has so much pressure and pain for the first hour or two I literally can not stand it ? same if I sleep on my back, etc). It is increased by even minimal exertion such as walking around the house. I have missed an extensive amount of work at this point because I am sent home almost every shift. For the first two weeks I had additional worrisome symptoms that were fortunately relieved with an increased, second course of prednisone. The first being intermittent difficulty with reading comprehension, basic math, spelling, following directions, etc. I am still mentally sluggish but it is not alarming as it once was. The other major concern regarded my heart. Particularly at night, with no apparent arrhythmia, I could feel a sensation that led me to believe my heart was not functioning properly. There was an unusual sensation accompanied by slight discomfort, seemingly exacerbated by the muscle relaxer I have taken nightly for at least a year. My anxiety and irritability worsened 24 hours after injection but to be fair I am unsure if that is related to vaccine or the symptoms themselves.   I have been to the ER and have seen 2 additional physicians, including my PCP twice. I have tried three courses of steroids, one at 20 mg x 7 days, two at 30 mg x 5 days. The ER gave me an IM injection of Ketorolac. As of yesterday, I have begun taking Lyrica, increased Topamax and added topical Diclofenac. I was also instructed to take Tylenol around the clock and tizanidine three times daily.
Information has been received from a consumer concerning her 23 year old daughter with no medical history, and no drug reactions/allergies, who on 08-FEb-2008 was vaccinated with her second doe of GARDASIL (lot# unspecified). Concomitant therapy included YAZ. Consumer reported that her daughter experienced "extreme" bleeding at the injection site after receiving the second dose of GARDASIL and the injection was very painful. Unspecified medical attention was sought. Subsequently, the patient recovered from her experiences. No further information was provided regarding these adverse experiences. Additional information has been requested.
Presented with generalized raised rash throughout extremities and trunk.  This is accompanied with Minor fever for 100 and coughing.
Narrative:  Patient received first dose of COVID-19 (Moderna) vaccine on 03/30/21. Had f/u with Dr. on 05/04 where patient reported that he started having headaches 5 days after his Moderna vaccine. Endorses constant headache through all hours of the day. APAP and ASA provide no relief. Dr. recommend MRI of the brain. Results have come back, no acute processes found. Pending further w/u for sinus congestion and mucoid sinus cysts. Patient has been referred to ENT.
patient received shingrix on 6/9/19. she came in on 6/19/19 and stated that the day after the vaccine she didn't feel well and she continued feeling sick until 6/17 when she felt really sick and "flu-ish". She felt better on 6/19 when she came into the store. She was not sure if these symptoms were a result of the vaccine. She did check her temperature between 6/9 and 6/17 and said it was about 99 degrees but she did not check her temperature on 6/17 when she felt the worst.
s/p injection c/o panic attack and rapid heart rate, sweaty, dizzy, tearful. No intervention required
night sweats; sleeping a lot; lethargy; overheated; sweating; he experienced pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (he experienced pain in his arm), NIGHT SWEATS (night sweats), SOMNOLENCE (sleeping a lot), LETHARGY (lethargy) and FEELING HOT (overheated) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (he experienced pain in his arm). On 20-Apr-2021, the patient experienced NIGHT SWEATS (night sweats), SOMNOLENCE (sleeping a lot), LETHARGY (lethargy), FEELING HOT (overheated) and HYPERHIDROSIS (sweating). At the time of the report, PAIN IN EXTREMITY (he experienced pain in his arm), NIGHT SWEATS (night sweats), LETHARGY (lethargy), FEELING HOT (overheated) and HYPERHIDROSIS (sweating) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Labyrinthitis of right ear with sudden profound sensorineural hearing loss and vertigo starting 3 weeks after vaccination, resulting in total deafness of right ear despite steroid treatment.
This spontaneous report as received from a registered nurse refers to two patients of an unknown age and gender. Patients were vaccinated with lot # (672962/0025AE) PNEUMOVAX23 in May 2012 (dose, route and site of administration not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, both patients experienced pain at the injection site. No treatment information was reported. The outcome of pain at the injection site was unknown. The relatedness for pain at the injection site is unknown for PNEUMOVAX23. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
On 10/18/2003 had fever of 103.4 F, chills, pain and itching at vaccination site, headache, extreme fatigue, and body ache. Vaccination was during the pustular stage. Site was tender and swollen.
New symptoms developed in the months after booster: muscle spasms in chest/ribs, arm numbness and burning sensation in extremities, worsening of fatigue, and finally inability to walk due to leg weakness.  Pt had previously been stable with medications and had normal MRI 1 year previously.
pt devel and went into a state of status epilepticus requiring sedation, intubation & ventilation; transferred to clinic for further care;
This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 06-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
24OCT93 sore throat x 1 wk; went to MD put on ATB;
Information has been received from a consumer concerning her 81 year old mother with a history of mitral valve condition and no drug allergies/reactions who on 01-MAY-2012, was vaccinated subcutaneously in right arm with a 0.65 ml dose of ZOSTAVAX (Merck, (Lot# not reported). Concomitant therapy included LYRICA, TYLENOL WITH CODEINE, ATIVAN and NEURONTIN. On 02-MAY-2012, the patient's right arm was hurt at the injection site. On 03-MAY-2012 (reported as the next day) the patient experienced whole body ached, toes and fingers were tingling, the patient had cramping and was feeling week. The reporter sated that the patient had been seen by several doctors and also she was seen at the ER and was put on VICODIN for pain. The patient underwent unspecified 'blood work" (results unknown). The adverse event did not improve. At the time of the report the patient's status was not recovered. Additional information has been requested.
The patient received a high dose vaccine and it should have been a regular dose flu vaccine> pt knows and had no adverse side effects.
Extreme tiredness, stomach pains, almost threw up, dizziness; same day as mmr vaccine. Now 5 days later still extremely tired, feeling unwell, stomach pains, forgetfulness( will ask a question, receive a response and shortly after ask the question again as if never asked.) Extreme nasal congestion. Not eating.
Information has been received from a registered nurse and the wife of an 80 year old male with arthritis NOS and penicillin allergy who on 9/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. Concomitant vaccination on 9/30/02 included influenza virus vaccine in the left arm. Other concomitant therapy included Norvasc, Celebrex, Lipitor, Prilosec. The nurse reported that following the vaccination, the pt felt achy, and tired and had a temp of 102.8. It was also reported that by the next day, the injection site was red and swollen, then the pt's whole arm became red, hot and swollen and the pt had a fever of 103 deg. The pt was seen by a physician and was treated for cellulitis and given Levaquin. The pt's wife reported that the physician believed that the cellulitis was caused not by the vaccine, but by the way it was administered. It was reported  that the vaccine was given without the injection site being swabbed with alcohol. Also, the injection site was not bandaged or covered afterwards. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent more than 5 years ago without incident. At the time of this report, the outcome of the events was unknown. No further details were available. No further info is expected.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of unspecified age and ethnicity received TRUMENBA (lot number L13514, expiry date Jul2016) via an unspecified route of administration, on 06Nov2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient was sick, with flu like symptoms, headache, mild cough, weak, fever, muscle pain and dizziness on unknown date. The patient had no vomiting. The patient was tested for the influenza virus through the nasal swab test and for mononucleosis it were negative. The events took place after the vaccination. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Information has been received from a 71 year old female patient with a history of shingles before receiving the vaccine and blisters around her lips since she was a child and no known drug allergies or reactions who on 2-OCT-2008, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # not provided). There was no concomitant medication. On approximately 9-OCT-2008 ("about 1-2 weeks after vaccination") the patient experienced outbreaks of blisters around her lips have been more common. Therapy with ZOSTAVAX (Oka/Merck) was discontinued. Routine labs were performed (no results provided). The patient's blisters around her lips persisted. The patient did not seek medical attention. Additional information has been requested.
Five year old male patient received Hib Vaccine outside of Protocol recommendations. Contributing factors: 1.  The child was starting over with vaccines at health department visit with no proof of prior vaccinations. 2.  The nurse who ordered the vaccines was not the nurse who performed the well child exam. 3.  Staff did not utilize the protocol manual to verify the age limit for administering a Hib vaccine. Via in house interpreter spoke with Father, by phone and he denies the child having any adverse reaction to vaccines.
pt recv vax 23AUG96 & 5SEP96 pt devel breakthrough chickenpox w/30 lesions on chest;pt father stated that to the best of his knowledge pt had not been exposed to chickenpox;@ time of report the lesions cont to pop up x 2wk;
A bad headache, site of injection soreness, overall tiredness and body aches .  Took three ibuprofen went to bed, feel better on morning of April 2nd.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 10-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 05-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Patient to ER for swelling/redness and itching at site and swelling of arm after injection.  Received antibiotic and steroid injection.
Approximately 3-4 days post injection of ZOSTAVAX patient reported severe headache which resolved in 2 days. Patient also reported increased muscle pains, as she usually suffers from muscle and sometimes joint pain. Muscle pains have decreased but are still present.
hives that began on face, then quickly covered face, chest, arms & legs; by 1PM the hives were completely gone;no fever, fuzziness;