chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented 5/10/07 with a ten history of tingling in the right hand.  On 5/14/07, she presented with right foot pain and numbness as well.  She was referred to the Neurologist where she had an appointment 5/15/07.  Patient was admitted, after ER evaluation, on 5/16/07.  Patient was treated with IVIG in the hospital and multiple tests were ordered.  Patient's working diagnosis is Landry-Guillain-Barre Miller-Fisher variant. 06/05/07-records received from facility for DOS 05/16-05/21/07-DC DX: Guillain Barre variant. Left Bell's Palsy. Paresthesias. C/O numbness in dorsum of right hand progressing up her forearm also left foot numbness progressing up her leg and a left facial droop. Numbness started in right hand approximately 1 month after received HPV, Hep A and Menactra vaccine. HX of living in woods and a family pet with ticks. PE: Crainal nerves II through XII intact with exception of mild left facial droop. Paresthesias of bilateral lower extremity and hands and arms in glove and stocking formation. Strength and motor intact. Treated with IVIG. Symptoms without progression and slight improvement daily. Lost reflex in lower extremities but at time of discharge 2+ of right but have not returned on left
This spontaneous report was received from a registered nurse regarding a 13 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA000142.
Child received Dtap #4 on 4/18/2005 Left Deltoid.  On 4/19/2005 mother reported that child's arm was red, swollen, and child was having low grade temperatures.  Mother took child to Emergency Room for treatment.  Child was diagnosed with Left arm Cellulitis, was treated with Motrin, Benadryl and Amoxicillin, and was released from ER.  On 4/20/2005 mother states child's arm was more swollen than previous day, and swelling was traveling down arm including elbow area.  Mother took child to ER. MD told mother that the child did not have cellulitis, but more than likely a reaction to the Dtap vaccine.  Child was given Decadron and released from ER, and told to follow up with pediatrician on the following day.  Mother took child to MD 4/21/2005 for follow up, and was told that the child did have a reaction to the Dtap vaccine, and to continue taking the antibiotic.  No other treatment or follow up was required by MD as per mother.
last night her ear glands that are under her ear at the neck area hurt her which is close to jaw bone meets her ear; feels achy all over her body; Sore throat; Cough; do not have any strength; intestines feels like she is cramping; feeling very sick; This is a spontaneous report from a Pfizer sponsored program (patient). A 67-year-old consumer female reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19May2021 at 10:00 hours (at age of 67-year-old female), in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included hysterectomy (start date and ongoing status unknown). It was mentioned that there was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines were administered and had no relevant family history. The patient did not receive any prior vaccines within 4 weeks. No adverse event following prior vaccinations. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 28Apr2021 (at age of 67-year-old female) in right upper arm as dose 1, single for COVID-19 immunization. On 19May2021 patient felt sick. Caller was wondering since her grandchildren would visit her today and wanted to know if her grandchildren would be contagious since she was sick. The same day about 6 hours after the shot is when it started caller stated she had a sore throat. She had cough, ten hours after the shot she felt achy all over her body, did not have any strength, her intestines felt like she was cramping, caller stated she knew that they were not menstrual cramps since she had a hysterotomy. On 20May2021 her ear glands that were under her ear at the neck area hurt her which was close to jaw bone meets her ear. Caller inquired if it was ok to call her family doctor would they know the answer. Caller stated she would just call her doctor The patient received treatment with Tylenol. She did not require any emergency room and physician office visit. No relevant test was reported. The outcome of felt sick was unknown and for intestines feels like she is cramping was recovered on 20May2021 and the other events had not recovered. Additional information was requested.
throwing up and is pooping and the throw up and the poop are black; throwing up and is pooping and the throw up and the poop are black; running a fever; This is a spontaneous report from a contactable consumer or other non-hcp. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6205; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 59-year) in left arm on 19Mar2021 as dose 1, single for COVID-19 immunization; time the Vaccination was given at 2:40 pm or 3:00 pm. Medical history included none. There were no concomitant medications. On 21Mar2021 the patient experienced running a fever; on 22Mar2021 the patient experienced throwing up and was pooping and the throw up and the poop are black. Prior Vaccinations (within 4 weeks) was reported none. The patient underwent lab tests and procedures which included body temperature: 99.6 degrees fahrenheit on an unspecified date in Mar2021. It was reported that "Caller stated she was calling for her husband who was the patient and had his 1st dose of the Pfizer Vaccine on Friday 19Mar2021; states he did ok and then yesterday he was a little down last night with running a fever; states today the patient was throwing up and is pooping and the throw up and the poop are black; states he was not having diarrhea. Caller stated even his throw up was black and last night the fever began and the fever was ongoing and just took his temperature which was 99.6 degrees Fahrenheit. Caller stated the patient began throwing up and pooping this morning and the throwing up and pooping are ongoing and the same as when they began. Caller stated the patient had not had treatment for the reported events, but she did call his HCP and the HCP prescribed a medication for him that he had not yet taken, and it was an over-the-counter medication that she does not know the name of and had no information to provide at this time. Caller states she was concerned that the throw up and the poop that the patient had were black and he told her the last poop he had was smelly and she does not know if this was a side effect of the Pfizer Vaccine or not, but it concerned her because the throw up and poop are black. Caller agreed to proceed with the report at that time and states she called Pfizer first to ask if that was a side effect of the Pfizer Vaccine but she was thinking of taking the patient to the hospital because he looks pale and she does not know if that was bleeding or could be a sign that blood was coming out and she doesn't know if it was caused by the vaccine or if it just started with something else in the patient. Caller stated there was not an expiry date or NDC on the patient's card for the 1st dose of the Pfizer Vaccine. Caller stated she had heard of side effects she usually hears that with the 2nd dose and not the 1st dose." The clinical outcome of the events "throwing up and is pooping and the throw up and the poop are black" was not resolved, while the outcome of another event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient given 1st dose Pfizer covid vaccine at 422pm  was sitting on bench shortly around 430 began to faint, was talking to mother on cell phone so she called me,  went to check on patient and was leaning  showing signs of syncope, elevated feet and seemed to be ok, then as was trying to lay her down she went out again completely,  at this point called ems,  However after we got her laid down and feet elevated was feeling ,much better by the time they came,  mother arrived and  they left.  Followed up with patient on 8/14 - patients mother said she was fine, they went immediately home after had no need to visit ER/DR.
Deep Vein Thrombosis right leg, superficial femoral vein to popliteal vein and distal
Information has been received from a physician concerning a 14 year old male who in April, 2000 was vaccinated with the 1st dose of Hep-B. In 2000, the pt experienced personality changes. The pt's personality changes persisted. No further information is available.
Information has been received from an RN concerning a 67 year old female pt who on 21JAN2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No to her vaccinations were administered at the same time. On 22JAN2004, the pt developed cellulitis at the injection site. Medical attention was sought. The pt was prescribed Cefzil and warm packs. A product quality complaint was not involved. Cellulitis at the injection site was considered to be an other important medical event. The reporter also mentioned three other pts who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional info has been requested.(OMIC)
Moderna COVID?19 Vaccine EUA on Sunday (6 days after receiving first dose) injection site was noticeably warmer than left arm and dull pain in the muscle.  By the following Wednesday (9 days after initial dose), noticeable red area around injection site and  experienced pain in the arm at  injection site and shoulder.  Pain continues and I experienced limited movement in the arm with restricted ability to raise arm over head.  Arm movement is better but continues to be painful in the shoulder and right side of neck.  Other than annoying, not too concerned nor do I feel it is necessary to contact my health care provider at this time.
Possible minor allergic reaction with itchy eyes, scratchy throat, funny nose, slight chest discomfort. Benadryl one dose on Sunday pm and one dose on Monday pm.
No adverse event experience. Submitting incident report because patient was 16 years old at time of immunization and manufacturer guidelines are for 18 years of age and older only.
Fever; Chills; Swelling Lymphnodes in both arm pits with associated discomfort; Headaches.
chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
one dose 4 years ago, 2nd not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 4 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Information was received on 14-OCT-2016 from a pharmacist who reported that an unspecified patient received a dose of ZOSTAVAX (lot number, dose, route were not reported) that had been "reconstituted and stored in refrigeration for 3-5 hours prior to administration" on 13-OCT-2016. No adverse effect reported. No other information was provided. Follow-up information was received on 18-OCT-2016 from the pharmacist who reported the lot number of the ZOSTAVAX that was administered: M019645, expiration 18-JUL-2017. No other information was provided. Additional information is not expected.
After the third dose there was no reaction until she suddenly had a stroke. I went to the hospital and stayed 3 days. I am starting to go to the specialist to control the medicine they gave me in the hospital.
pt recvd MMR vax & exp redness, warmth & 4+ edema @ inject site on the arm; no further details were provided;
Patient missed dose this am, she then informed that Tuesday evening between 1600 and 1700 that she developed hives all over her body. Patient informed that she visited Urgent Care on two separate occasions last week and is currently taking Prednisone and Hydroxyzine.
This spontaneous prospective pregnancy report was received from an office administrator referring to a female patient of unknown age. The patients medical history or concurrent condition were not reported. On an unknown date, a dose of M-M-R II (lot#, expiration date, dose, dose number, route were unspecified was inadvertently administered to the patient who was currently pregnant (last menstrual period (LMP) and estimated due date (EDD) was not provided). No adverse events were reported at the time of the call. The pregnancy outcome was pending. Additional information has been requested.
Reported to office patient deceased. 9/22/08-autopsy report received-COD sudden unexpected infant death associated with inappropriate sleeping environment. Found dead while sleeping on an adult mattress on floor with pillows and blankets. Anatomical diagnosis:Thymic petechiae. Pulmonary edema. Cerebral edema. Medical intervention. Facial abrasions, mild and tongue contusion.
syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient).   A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation.  Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility.  No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Approximately 4 days after receiving J & J vaccine, patient develops erythematous, pruritic, raise migratory rash.  She is hypertensive at 174/95.   Patient has been taking diphenhydramine 75mg  per dose , famotidine and loratadine at home, but rash continues to worsen.  She is seen in the ER on 5/4 and 5/5.  Patient is treated with epinephrine 1mg IM with good response.  Blood pressure improves after epi to 132/61.
injection site has mild soreness; a weird taste in my mouth; constricted my throat/a tightness in the back of my throat, as though the glands were swollen; a tightness in the back of my throat, as though the glands were swollen; constricted my throat making it uncomfortable to swallow; discomfort; felt weakness in my whole body; walking felt strange; This is a spontaneous report from a non-contactable consumer (patient) reported herself that a 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/ lot number: EN6207), via an unknown route of administration in left arm on 13Apr2021 at 09:45 as single dose (at age of 41-years old) for COVID-19 immunization. The patient's medical history included diabetes mellitus from an unknown date to unknown if ongoing. No known allergies. Concomitant medications were not reported. No other vaccine in four weeks. Other medication in two weeks was multi-vitamins. On 13Apr2021 at 09:45, the patient experienced injection site has mild soreness even 24 hours later. Shortly after injection, during the initial 15 minutes waiting period until 5 or 6 hours later, there was a weird taste in her mouth and a tightness in the back of her throat, as though the glands were swollen and constricted her throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. She also felt weakness in her whole body and walking felt strange and lasted for the entire day. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for events. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
1/7 developed pain and bruise at injection site, reports she ?bruise easily?.  Pain continues as of 1/27  1/10 developed ?manic episode? reported as insomnia, anxious, unusually irritable, racing thoughts, resolved 1/22.  This was described as the ?worst reaction? encountered since vaccination, but was only reported as an after thought when closing the interview.  1/16 developed hives on abdomen and flanks  1/17 developed hives on abdomen, flanks, back, but late evening hives on legs, arms, ?head to toe?. Applied calamine and oral diphenhydramine with some relief-patient described as a ?ton of Benadryl?, but could not quantify dose  1/25 left arm numb from fingertips to left shoulder above injection site  Asked if she shared all symptoms with PCP including numbness in arm, replied yes and follow up appointment on 1/29/21
At 3:25pm patient was to be discharged from observation - stated throat felt thick, + lightheadedness. No SOB. BP 121/80, HR 79, RR 14, Sat 99, Observed additional 20 mn by RN. Symptoms resolved. Repeat BP 129/75
pt recv vax 24JUN98 & same afternoon noted onset of numbness & tingling several hr later;denied redness, swelling or drainage from inj site;denies fever, chills or sweats;no visual disturbance or numbness or tingling of lower extremities;
had one flu shot in my life and was so sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Dec-2020.  This case involves a patient of unknown demographics who had one flu shot in his/her life and was so sick (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient had one flu shot in his/her life and was so sick (Illness). The patient has not had the flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.  No further relevant information was reported.
Red area, approx. 5 cm x 5 cm on (R) arm - swollen and warm to touch with pain reported when stretching out his arm. Treatment - OTC pain medication.
Got a little sick with first and second shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got a little sick with first and second shot) in a 94-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Flu: Flu shot (Given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got a little sick with first and second shot). At the time of the report, ILLNESS (Got a little sick with first and second shot) outcome was unknown.      No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-599999 (Patient Link).