chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008613, 1209USA008614. Additional information has been requested.
After receiving a PREVNAR vaccine, patient experienced redness, swelling, and low grade fever for 2 days. Got better.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 07-DEC-2015, the patient was vaccinated with a properly stored but expired dose of VARIVAX (Merck) (lot # J013066; expiration date 16-OCT-2015) 0.5 ml, subcutaneous. Concomitant medication was not reported. No adverse reactions reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient had pain and redness at the site within the first day.  On day 5 she started to develop a painful red rash on her feet.  She went to the ED on October 4 and was found to have elevated platelets and WBC.  She was seen in my office on October 9, platelets and WBC increased.
Late 2nd dose due to vaccine availability/way beyond the approved scheduled time due to vaccine availability during that time; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 to 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: No additional information was provided. Lot, expiration and dates of vaccines were not provided. The customer wanted to disconnect from call. The customer did not provide additional information or demographics.  The customer just only wanted her question to be answered and disconnect from call. Additional supportive information: The patient got her 2nd dose of Shingrix way beyond the approved scheduled time due to vaccine availability during that time, which led to product supply issue.
inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event; Initial information received on 15-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old and unknown gender patient who experienced inadvertently administered adacel to a 17 month old patient instead of dtap, with no reported adverse event while receiving diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (with an unknown strength, dosage, frequency, batch number and expiry date) via unknown route in unknown administration site for immunization  On an unknown date(latency : same day) the patient developed a non-serious inadvertently administered adacel to a 17 month old patient instead of dtap, with no reported adverse event (accidental exposure to product) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event (inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event).   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 guidelines. 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.
Five minutes after receiving the vaccination my left arm started to feel warm. When I pushed up my sleeve I had a red spotted rash on my skin. I alerted the vaccination staff and they noted the rash was also on my chest and neck. My pulse was erratic and low. Out of an abundance of caution I was taken to the ED by ambulance. I did not experience any facial swelling or difficulty breathing.  At the ED I was given IV and antihistamines (diphenhydrAMINE and famotidine). I was given a second dose of diphenhydrAMINE about 90 minutes later when the rash started to return on my arm.
has a bad hip which has gotten seriously inflamed; really intense muscular pain; Chills; trouble sleeping; Lethargic; achy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and MYALGIA (really intense muscular pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hip discomfort.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and CHILLS (Chills). On 31-Mar-2021, the patient experienced ARTHRITIS (has a bad hip which has gotten seriously inflamed) and MYALGIA (really intense muscular pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy), MYALGIA (really intense muscular pain) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided by reporter.
Muscle soreness, extreme fatigue, headache for next two weeks. Shingles (mild case) on left leg started one week later (11/25/12).
Patient received PNEUMOVAX around 10:30am and BOOSTRIX around 10:45am on 4/23. Patient had received the SHINGRIX vaccine (lot T5242) on 4/11 on the left arm about 11am. Patient had small bruise at injection site where SHINGRIX was given. Patient came back to pharmacy 4/24 around 10am to have pharmacist look at arm where she had received the PNEUMOVAX. The area was red and raised. The pharmacist marked the area with a pen and told patient to watch to see if area got bigger. Patient returned to pharmacy around 5pm to have it looked at again. The borders had increased about a half inch and was warm to touch and raised-area was (4x6 1/2). We consulted her to be evaluated by physician in case of cellulitis. The patient went to the walk in clinic where they did not give her diagnosis. They marked area with pen, gave her a steroid shot, and prescribed Cephalaxin 500mg bid. Patient came to pharmacy 4/25 around 10am to have area looked at. The redness and area of swelling had started to decrease from markings made by doctors office.
Post vax, the pt developed a localized reaction with redness, swelling, and a knot.
Patient presented to emergency department 7/20/21 with shortness of breath beginning several days prior to admission and progressively worsening. Diagnosed with COVID-19 pneumonia with superimposed bacterial pneumonia. Treated with dexamethasone, vancomycin, cefepime. Currently on day six of hospitalization requiring 15LPM of oxygen.
Severe chills,  severe body aches,  severe sore injection site,  splitting headache,  temperature 101 2days, 100 3rd day, fever normal by 4th day. IT WAS HORRIBLE
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ  11/9/2022 --  RECURRENCE OF SAME SYMPTOMS
On 01/21/2021 had Covid 19 Vaccine shot #1 in right arm.  About seven days later got rash around shot site but went away in a our four days.
Arrived at clinic 10 days after injection of FLUVIRIN. Reported that arm had been red and swollen a few hours after injection and that several vesicles appeared at the site 2 days later.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.    The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant and treatment medications were reported
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Patient was given H1N1 vaccination 0.25 mg (to a 12 mos old child) and vaccine stated it was for 4 yrs and up.
Temp 99F on 4/29/03. 7 month with 2 or 3 erythematous macules on trunk. Brother had chicken pox about two weeks earlier.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Hypertension-Severe, Additional Details: The patient states that she has not been able to return to work due to the side effects experienced after receiving the vaccine.
Received FLUMIST 12/26/2006. Within 5-10 minute he complained of being dizzy (room was spinning when he looked up), had mild shortness of breath, and felt his heart racing (as if just finished running). Bystanders reported he appeared wobbly on his feet. He remembers lying down on the floor and medical personnel saying his heart rate was 170-180. He denied any loss of consciousness, blurry vision, chest pain, sweating, nausea, weakness, rashes, or swelling. He denied any prior illness or current viral illness, and did not remember eating prior to this event. He advised the tachycardia lasted about 5 minutes, shortness of breath sensation 15 minutes, and dizziness 45 minutes before fully resolving. He was released to follow up with his primary care provider for further evaluation. He advised driving home without return of any symptoms and has never completed further follow up. A review of this service member's electronic medical record  identified further influenza vaccinations were given 1/8/2007 (IM-500428P) and 10/6/2009 (nasal-500691p along with TYPHOID VI booster IM). However he does not remember receiving these vaccines in either 2007 or 2009 or having any adverse events if he did.
I had an upper respiratory infection so I developed a cough that hadn't cleared up in about a week. I was treated with steroids' previously, I didn't want that again so I went to urgent care, I was told it didn't seem like the same thing so I was given on February 13 some prescriptions. About a week later the shingles that developed started to get worse with pain, I was on an antiviral.
Pt recvd a series of 3 Engerix-B doses 8OCT90, 12NOV90, 8APR91 & was poss non-responder;
No adverse effects; Patient was administered improperly stored GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ reactions and concomitant medications were not reported. On 21-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, formulation, route, dose/frequency were not reported) lot # R016970, expiry date: 22-MAR-2021 for prophylaxis. On 21-AUG-2019, the patient was administered with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product storage error). No adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Arm is sore; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-1021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-079975 (E2B Linked Report). This case was linked to MOD-2021-079975 (Patient Link).; Sender's Comments:  MOD-2021-079975:First dose case
feeling tired; red rash around injection site; red rash around injection site; pain under armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit), FATIGUE (feeling tired) and VACCINATION SITE RASH (red rash around injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Ibuprofen) and Bee sting hypersensitivity. Concomitant products included PROBIOTICS NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit) and VACCINATION SITE RASH (red rash around injection site). On 11-Aug-2021, the patient experienced FATIGUE (feeling tired). At the time of the report, VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit), FATIGUE (feeling tired) and VACCINATION SITE RASH (red rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information does not provided by the reporter.
The father reported that the patient had a raised red induration on the left thigh. It was about the size of 1 1/2".
it stopped and broke out again; red wheals broke out 3 inches below the injection site; A spontaneous report was received from a healthcare professional concerning a female patient of 76 years of age who was  his wife ,administered with Moderna's covid-19 vaccine and experienced red wheals broke out 3 inches below the injection site.  Patient's medical history was not provided.Concomitant medication included Pravastatin.  On 13-JAN-2021,prior to the onset of events,the patient received their first of two planned doses of mRNA-1273(Lot number:028L20A) for prophylaxis of covid-19 infection.  On 13-JAN-2021,the patient received Moderna's covid-19 vaccine on the left arm.Next day red wheals broke out 3 inches below the injection site.Then it stopped and broke out again on 22-JAN-2021  in the same place.Treatment  for the event included Benadryl.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the 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 was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Probable meningococcal, Hepatitis A, and tetanus vaccine unmasking of  Relapsing-remitting multiple sclerosis (RRMS); Literature Report: This literature marketed report has been received from the authors of the published literature article entitled as above regarding a late 40's patient of unknown gender, who was part of a study that evaluate the prevalence and clinical characteristics iatrogenic central nervous system (CNS) inflammatory events of a total of 27 patients in a tertiary neuroimmunology clinic over five years from January 2017 and December 2021. The patient's pertinent medical history included autoimmune Grave's disease; previous drug reactions or allergies and concomitant medications were not provided. The patient did not have any cancer history.  On an unknown date, the patient was vaccinated with meningococcal, Hepatitis A, and tetanus vaccine (manufacturers unknown) (doses, vaccine schemes, routes, lot numbers and expiration dates were not provided).   After 7 days of the last dose of the vaccines, the patient experienced probable meningococcal, Hepatitis A, and tetanus vaccine unmasking relapsing-remitting multiple sclerosis (RRMS) with spinal sensory attack. The Naranjo Adverse Drug Reaction Probability Scale result was 7 and was used to score the probability of iatrogenicity.  Treatment with intravenous methylprednisolone (IVMP) was given with "none" response. The final disease course was reported as RR (prior spinal CIS). The outcome of the event was not provided.  The causality assessment between the event and the suspect vaccines was considered to be related.  Upon internal review, the event relapsing-remitting multiple sclerosis (RRMS) was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article.; Sender's Comments:  US-009507513-2303USA007194:MSD
Constant back pain in mid to lower back since second dose. Physical therapy not helping. Pericarditis diagnosed 1/5/22 causing chest tightness and pain.
On July 2, 2022 I started to experience sneezing, runny nose, congestion, coughing, no fever. On Sunday I felt fine just a dry cough but by Sunday evening I developed a wet cough and headache. I took a nap and woke up not feeling well so I took a home COVID-19 test it showed positive immediately. I called my doctor and had a telephone visit with my doctor. She prescribed Paxlovid and I started taking it Monday night. I took another test Monday morning with the same results. I went in to drive through clinic to have a PCR COVID-19 test. I already had diarrhea but it much worse now, I have chills, fever, sleeping restlessly, whenever I sneeze my whole body aches. My fever is holding at 102F, I am taking Tylenol. I started having brain fog on Monday and Tuesday, having trouble concentrating, nausea, vomiting.
17 minutes after receiving 3rd pfizer vaccine patient reported throat swelling and itching. Gave 50mg diphenhydramine and sips of water, had patient sit quietly in exam room under observation. Within 15 minutes patient reported significant improvement. Counselled that could feel sleepy and to have additional diphenhydramine on hand for the future. Released to wife for further monitoring.
Headache, NauseaVomiting, FATIGUE,CHILLS, SORENESS AT INJ. SITE Narrative:
On the 30th, my knee started swollen and hurting. I could barely walk about 2 weeks it moved to my back. I ended with a hernia disc. Soreness in my joints in my hand, knees, fingers, and back. Like traveling Joint pain and swollen.
patient received TENIVAC by mistake. The patient was supposed to receive PREVNAR with no adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 65 years old male patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] by mistake. The patient was supposed to receive prevnar with no adverse event.  The patient's past vaccination(s) included TENIVAC  in 1998, TENIVAC  on 18-Jan-2018, ADACEL and 5 doses the last 24 years of TETANUS and DIPTHERIA.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 22-Aug-2022, the patient received 0.5 ml total, 3rd dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation and lot number: unknown) via intramuscular route in unknown administration site as Immunization.  On 22-Aug-2022 (latency: same day) the patient developed a non-serious event "patient received tenivac by mistake. the patient was supposed to receive prevnar with no adverse event (wrong product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    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.
Second dose was on 01/25/21 - two months following I had felt lateral left breast pain, followed by a pulsating sensation in my left axilla, on and off for the past 5 months. breast pain has gone away but there is still pain and on and off pulsating of the axilla.
I have had some ringing in my ears for several years.   I received the Jansen Covid vaccine 03/10/2021 and did not have any noticeable effects.  When I got the Pfizer booster shot 11/02/2021 I started to notice the loudness, frequency and tone of the ringing getting worse in about a week.  It is now constant loud ringing.