chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little disoriented; Mildly confused; had tightening of the throat; Felt like she couldn't swallow; Slight swelling of mouth; Mouth felt strange; ear felt strange; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow) and MOUTH SWELLING (Slight swelling of mouth) in a 45-year-old female 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange). At the time of the report, DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications were reported
Mother called??patient started with hives-like rash on 9/21 on the upper and lower back. No fever, no other symptoms. No changes in soaps, detergents, fabric softeners. Concerned about association with vaccine??Menactra given. No local injection site symptoms. With Benadryl, hives are dissipating.   Recommended Zyrtec 10 mg daily until rash is gone.
Patient received 1st dose on 10/15/21. Patient returned on 10/29/21 and received 2nd dose 2 weeks early.
Pt has previous hx of severe Covid infection without any medical records from the hospital stay (unaware what treatment she received) more than 6 months ago.  Patient's husband reported on behalf of patient, she experienced COVID arm (red, swollen , knot present and very sore), extreme fatigue and fever greater than 103F for a couple of days post vaccination,  She felt run down and "sickly" for approximately 2 weeks post-vaccinations and refused the second dose.
1 day after vaccination (03/08/2021): pain and swelling at injection site, fever, chills, fatigue, lasting one day.
Child crying non stop since 4 mo shots this morning. Child refusing bottle, fussy, crying. Abdomen taut. Increased crying when supine. Child sent to ER via ambulance for evaluation.
patient stated before vaccine she was nervous and might cry. (patient was visibly shaking and stated when she was younger she had a bad experience so that is why she was nervous.) Once vaccine was given pt asked if that was all because it didn't hurt and didn't cry. Approx 2 minutes later she alerted that she wasn't feeling so well and thought she may vomit. A bucket was then retrieved and 1 moment later patient had fainted/ experienced a seizure. Patients body went rigid (legs, arms, neck) and at head was turned downward and to the right. Her eyes were dilated and she was staring straight ahead. Approx 45 seconds went by before patient started to come around. She stated she could hear me when this was occurring however she was extremely pale, and because very sweaty. Her blood pressure was then taken and 1st reading was 56/37 at 1:35pm. EMS was called as soon as she fainted and was on the scene within 5 minutes. Paramedics then took over and performed another BP check which was then 88/61 at 1:45pm. EMS evaluated her, called her mother and stayed with the patient until she was released to her brother and walked out of the pharmacy on her own.
Pt had shingles shot at pharmacy on 11/16/2015 and on 11/18/15 he had an outbreak of shingles.
Information has been received from a practice manager concerning a 24 year old female patient with rash who on 14-MAY-2007 was vaccinated IM in left gluteus with Pneumovax 23 lot# 654977/0888F. The reporter stated that patient was having increasing fevers after getting the Pneumovax 23. The fever started out as mild then went really high. Since 15-MAY-2007 patient had been taking Advil. As soon as the Advil wears off the fever comes back and then goes up. On 16-MAY-2007 patient had a temperature of 103 F then she took Advil and fever went down to 99.2 F then the fever started going up to 102F. The patient's fever persisted. The reporter has requested A lot check on behalf of the physician. The reporter indicated there was "other patients" who received Pneumovax 23 lot#654977/0888F and subsequently "got ill". The records of testing prior to release of the lot in question, having been rechecked and found to be satisfactory. The lot complies with the standards, and was released. Additional information has been requested.
Patient got 1st dose on 05/20/21 and 2rd dose of vaccine on 07/13/21  53 days after 1st dose. No adverse  effect was noticed
The pt had vaccine 8/4/16 and on 8/5/16. Started w/Sever muscular and joint pains. Difficult to move. No fever, no swelling or redness. Upper back, fingers, knees and buttocks involved.
Flu like symptoms; Muscles aches, feverish, headache, fatigue, Staring 11 hours after 2nd Covid 19 Vaccination   Lasted approx. 18 hours.
Flu like symptoms, large, inflamed red raised swelling. Itching and pain at injection site.
Woke up 10-3-17 very sick, fever, nauseated. Couldn't get out of bed all day. The rest of the week I felt nauseated, itchy, wheezing when I would take a breath. I took ADVIL to help with the pain.
pt recv vax 4SEP97 & 5SEP97 pt had fever, chills, soreness @ inj site, pain in shoulder & elbow joint (lt);did not take temp;6SEP redness about size of silver dollar just under inj site;7SEP redness 130mm x 60mm;redness still but dec;
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer Vaccines 1/23/2021 and 2/13/2021. Presented to ED 6/10 w/SOB x 1 wk. Recently vacationed. On 6/4, he developed URI sx and went to outside ER where he tested negative for COVID, but + for flu. Prescribed tamiflu and doxycycline x 5days. SOB worsened; readmitted to outside ED where he was intubated for resp dist and transferred to facility. In the ED, afebrile w/HR ranging 90s-100s, and hypotensive requiring levo. Req'd Vent settings of 100/20. Labs significant for BSG 325, Cr 4.0 (baseline around 2.5),cont K 5.9, CO2 20, procal 0.09, trop 0.75, BNP 1000, Lactate 2.5, ABG with pH 7.28, pCO2 46. Hgb normal WBC 12.4. COVID+, flu negative. CTA without PE but w/multifocal PNA. Admitted to ICU. During stay, pt experience uncontrolled hyperglycemia which was tx'd multiple times with lokelma,insulin, ca glu, and bicarbonate. Volume overloaded but unable to diurese given his shock and pressor requirements. Cont'd to decompensate with hypotension and hypoxia. Transitioned to DNR/COT status. Tx'd with remdesivir, cefepime, and decadron. Pt expired on 6/14/22.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .
Client came in with Hx of previous J&J shot on 3/20/2021 and Pfizer booster on 10/26/2021, seeking Pfizer. Staff missed screening client out or being ineligible for further vaccination and client was given a full dose of Pfizer on 01/12/2022.
received a dose from a punctured vial after the 12 hourtimeframe in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hourtimeframe in the refrigerator) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hourtimeframe in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hourtimeframe in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received included no new information
Notes per office visit on 1/17/13 for R arm pain: [Patient History] Received vaccines in right arm 2 days ago (15th).  Has developed severe pain at sites, unable to move her arm without the use of her other hand (to assist).  Can't care for her 8 month old.  Feels swollen.  Had been having fevers to 103, for which she took ibuprofen, but those have resolved.  Ibuprofen not helping with her arm. [Physical Exam  R arm]  No upper arm erythema, upper arm swollen, deltoid muscle tenderness noted, reduced shoulder abduction, reduced shoulder adduction.  Skin pallor noted in involved area. [Treatment]  Naprosyn 500mg 1 po BID prn pain/fever, # 30;  Tylenol #3, 300-30 mg, 1 or 2 Q4-6 hrs prn w/ food, # 20.  Patient to return prn.
I tested positive for Covid-19 on July 15, 2022.  I had very few symptoms except being a little more tired than usually.
second shot was pretty rough, glad it's over; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that second shingles shot was pretty rough, but glad it was over. Additional supportive information: Follow-up would not possible as no contact details were available.
Had usual flu symptoms before going to bed that were mild, BUT woke up around 4am with severe back ache on left side below rib cage and it hurt so much that I could barely walk.   At first, I thought it was some kind of a kink in my back, but after doing some research, I discovered that it was my spleen that got swollen and was pushing against rib cage on left side.  Symptoms continued to increase until about 9am and then began to slowly recede after this.  Today is 4/17/21 5:39pm and I still ache in this area, but it is very mild compared to symptoms I got on April 15th.
Local allergic reaction to pneumococcal vaccine.   Nurse follow up on 08/04/04 states: "no new information."
2FEB93 pt devel t102 & h/a; On 3FEB93 inc temp, h/a cont & pt became very pale; pt seen by MD dx w/ear infect & prescribed ATB;
This clinician was alerted by Pharmacy that the Covid PFizer Booster dose (given at 09:12 AM) was inadvertently mixed with sterile water as the diluent; and therefore advised to immediately re-boost the patient according to the current CDC Guidelines.  The patient was alerted of the incorret diluent and recommendation to re-boost. The patient returned to this clinic on the same day in the afternoon for the re-booster Pfizer dose. A new dose of the Pfizer vaccine was mixed with normal saline as the diluent by Pharmacy. The patient reported no vaccine side effects or symptoms from the Pfizer dose given at 09:12 AM. The patient remained afebrile, and reported no side effects from the influenza vaccine given on the same day.  After the patient's verbal consent, the Pfizer vaccine re-boost was given at 3:02 PM. A courtesy follow up phone call was made to the patient Tuesday January 11, 2022, a message was left for the patient  to call back with any questions. No return phone call from the patient to this clinic as of today 1/14/2021 3:12 PM.  Pfizer, the manufactuer of the vaccine, was notified of the incident.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported) (lot number L043622, expiration date 03-NOV-2017; lot number L031066, expiration date 18-AUG-2017; lot number L035124, expiration date 14-SEP-2017). No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.   This case was linked to MOD-2021-395985 (Patient Link).
A non-serious spontaneous report of expired FLUMIST was administered was received from a pharmacist concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 27-Nov-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol. Pt contacted and no adverse reaction, pt states no problems
On 12/25 experienced intense uterine cramping. I?ve had a uterine ablation (2009( and have only had minor spotting a few times per year since. I have very mildly cramping 1-2 times per year. This was mid cycle  extremely intense. I had some minor spotting  the next day.  I have since found multiple others that experienced menstrual irregularities within 24-48 hours of injection.
On March16-2021 I started to feel tingling in my right ankle around 6:00pm, on March 17th I woke up with the same tingling in both ankles, sometimes the tingling is stronger in one ankle than the other, on March 20st I started to feel some burning sensation in my lower abdomen. Yesterday I started to feel tingling in my right upper hip, upper back both legs. Today March 21st I my right leg is itchy and my left arm is tingling and itchy. They don't disappears, the tingling some times is reduce
Redness and rash at injection site, rash on left lower arm. Soreness in arm for 48hrs and some fatigue.
I have experienced a hypersensitive sense of smell since receiving the vaccine and constantly smell cigarette smoke when there is no one smoking.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 17:30 (Lot number: Fc3182) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 17Aug2021 18:00, outcome "not recovered", described as "I have experienced a hypersensitive sense of smell since receiving the vaccine and constantly smell cigarette smoke when there is no one smoking.". Therapeutic measures were not taken as a result of parosmia.  Additional information: The smell comes in waves with the odor being strong and more nauseating at times than others. Patient not currently positive for COVID-19 nad not tested positive in the past.   Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
itchy rash; random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.) and RASH PRURITIC (itchy rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.). On an unknown date, the patient experienced RASH PRURITIC (itchy rash). The patient was treated with AZITHROMYCIN at a dose of 250 mg once a day and LORATADINE at a dose of 2 mg once a day. At the time of the report, RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.) and RASH PRURITIC (itchy rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided
Patient started to feel numbness in arm down to her hands approximately 2 hours after recieving vaccine in her left arm which lasted for few hours.  After numbness has gone, Patient still had severe pain in her left arm which inhibited her from daily functions like clothing, getting herself up from chair.  The pain lasted for about 4 full days.  Today is 5th day and patient feels better and able to move arm to drive a vehicle, but patient still complains of pain in left arm which is definitely better than past 4 days.
Headache; Confusion; Bilateral lower extremity weakness; Shaking; This is a spontaneous report from a contactable nurse (patient sister).   A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on Sep2021 as dose 3, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia, anxiety and sleep disorder from an unknown date and unknown if ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE via an unspecified route of administration, on unspecified dates as dose 1 and dose2 , single for covid-19 immunisation. Concomitant medication included gabapentin, Trizedon, paracetamol (TYLENOL,) all taken for trigeminal neuralgia, bupropion taken for anxiety, all start and stop date were not reported. The patient had confusion, bilateral lower extremity weakness and like she gonna 'eat them pretty much' (Not clarified), shaking and a headache was admitted in the hospital on Tuesday (14Sep2021), she was still in the hospital. It was reported that patient was in hospital because of possibly related to booster vaccine. Patient was treated with IV steroid, she is going physiotherapy and for headache they gave her tore ball. The patient underwent lab tests and procedures which included on Sep2021 computerised tomogram, echocardiogram, full blood count, x-ray, magnetic resonance imaging: unknown results and on 14Sep2021  Complete blood count (CBC), comprehensive metabolic panel (CMP): unknown results. The outcome of the event was recovering.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.