chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 2:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022 at 2:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received Shingrix (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 12th August 2018, the patient received the 1st dose of Shingrix (subcutaneous). On 12th August 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain and pruritus to be related to Shingrix. Additional details were provided as follows: The healthcare professional stated that the patient was given a dose of Shingrix subcutaneously, which led to Incorrect route of drug administration. Soreness and itching lasted for 1 day. No further details was provided.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.
Immediately after the vaccinations, patient started to run a fever.  Not too alarming, except the fever persisted for weeks.  I brought him back to the doctor's office to get checked for strep and an ear infection, but he just seemed to have a virus that wouldn't go away.  He then developed hand, foot, and mouth disease which took a couple of weeks to recover from.  During this time (starting immediately after the vaccine and for the next eight weeks) He first grew distant (which we attributed to not feeling well), then anti-social, stopped responding to his name, stopped talking and babbling, started doing lots of repetitive actions, and is now diagnosed as autistic.  NONE of these symptoms were present BEFORE his vaccinations, and seemed to come on one after another very suddenly immediately AFTER his vaccinations.
I had painful swelling of the testicles within the first 24 hours. They were hot, red, very much enlarged and extremely painful. I had a mild fever (99.4) which was about 2 degrees above normal. The selling has subsided in the second 24 hours and my temperature returned to normal. There is still moderate swelling and sensitivity. I had not seen this reported as a common side effect of the vaccination. I thought it should be reported.
neurologic episode; This case was reported by a physician via call center representative and described the occurrence of neurological symptom in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was recovered/resolved.   The reporter considered the neurological symptom to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was selected as adult as per vaccine indication. The reporter stated that they saw a patient for a physical and the patient reported a neurologic episode that lasted 4-6 weeks after receiving the Shingrix vaccine and they thought the reaction was due to the Shingrix. No additional details were available. The reporter was consented to follow up.
Right thigh - large induration area & tender to touch. Left thigh   - smaller area induration & tender to touch. Low grade fever - cool compresses, MOTRIN, TYLENOL was given ZITHROMAX 200mg/5ml one tsp today 1/2 tsp next 4 days.
Complained of pain shortly after receiving injection.  Severe pain caused limited range of motion.  Presented with complaints nearly 4 months after injection.
Enlarged, huge swollen axial arm lymph node, fever x2 days, nausea, diahreah, chills, pain in neck,
after vaccination, patient fainted but was conscious after couple seconds. asked if she was ok she stated she was fine but felt nauseated, was given water and crackers and remained at the pharmacy for additional 20-30 minutes for monitoring.
Case number PHEH2014US025101, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 62 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Patient complained of bad migraine-like headache for 3 days after administration of vaccine. Also developed 2 spots in the body red around & brown inside.
Swell, redress, + didn't improve  Doctor prescribe Antibiotics to treat infection and patient see improvement since. Doctor visit date on 9/20/2020
pt recvd vax & exp headache & general achiness 3 days after vax; stomach cramps & diarrhea 7-8 days after vax;
flu like symptoms; chills; Fever; body pain; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL 9267) via an unspecified route of administration, administered in Arm Left on 13Feb2021 13:00(age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't had covid prior to vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medication Lisinopril 10mg 1 tab daily within 2 weeks of vaccinations. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EL9261) via unspecified route of administration in Arm left on 23Jan2021(age at vaccination: 55 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not tested for covid to post vaccination. On 14Feb2021 10:00 the patient experienced flu like symptoms, chills, fever, body pain. No therapeutic measures were taken for the events. The outcome of the events influenza like illness, chills, pyrexia, pain was recovering.  Follow-up attempts completed. No further information expected.
After patient received the Pfizer Covid-19 vaccine, they stood up and and walked a short distance and then passed out on the floor hitting their head on the floor.
PATIENT RECEIVED VACCINE ON 10/7/2004 AND ON 10/21/2004 SHE AWOKE WITH FACIAL PARALYSIS, LATER DIAGNOSED AS BELL'S PALSY. Medical Records received on 1/20/2005 states pt experienced ptosis, pain, headache, hypertension and conjunctivitis.
Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter
Heart rate dropped to low 40. (She doesn't have any heart problems at all per Cardiologiat. Difficulty breathing,  Very bad headache, Oxygen saturation dropped to 88 % Blood pressure dropped too low (NO Hypertension medication were taken at that days) Syncope event Doctor suspected micro Clott formation after booster shot.
Pink, solid rash on back of neck for first four days.  On 3/12/15 I noticed distinct red spots on his neck, head, and upper chest.  The spots lasted for 3 days.  Also had a low-fever (101 F) with the spots.
Admit date 9/13/21 Pt admitted for acute respiratory failure and COVID PNA;  Comprehensive problem list: acute hypoxemic respiratory failure, refractory hypoxemia, COVID PNA,  cardiac arrest, coronary artery disease status post CABG, probable pulmonary embolus, colitis, COPD on home O2, chronic hypoxemic resp failure, insulin dependent diabetes mellitus, depression, GERD, hypertension, anxiety and panic attack Pt has end stage renal disease; had fever and weakness; O2 saturation was 70% on 3L cannula that he wore all the time; treated with vapotherm and non-rebreather mass which was ineffective; switched to bipap which worked well in the er; transferred to icu; became hypoxemic; intubated with 7.5 ET tube and arrested 10 min later; cpr ensued, 4 separate codes because of recurrent problems ekg showed some nonspecific st-t changes; heparin given, low oxygen levels that could not be increased, 2nd arrest, cpr given; sister was called, determined that no further cpr would be given; allowed to have continued support until his heart quit and pt passed away.
2 days p/shot aches & pain in joints, fever under 100, h/a, sinuses, discharge from nose & eyes-post nasal drip; MD prescribed 10 day of ATB;
Patient reported via phone call that on the 2nd day after receiving SHINGRIX immunization that there was a rash below the injection site. The rash is closer to the injection site but between the site and elbow.
RECEIVED PHONE CALL FROM PATIENT. PATIENT COMPLAINED OF FEVER AND NAUSEA 6 DAYS AFTER VACCINATION. PT ALSO, COMPLAINED OF REDNESS AND TIGHTNESS OF MUSCLE AT SIGHT. EXAMINATION OF INJECTION SITE BY NURSE APPEARED NORMAL. PATIENT TREATED WITH ORAL NSAIDS AND BENADRYL. ADVISED TO GO TO ER IF ANY ORAL, FACIAL SWELLING, DIFFICULTY BREATHING, TWITCHING. PATIENT STATED SYMPTOMS ABATED LATER SAME DAY.
Information has been received from a registered pharmacist concerning a 67 year old female patient who on 03-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). It was reported that on 13-OCT-2010, the patient called to the pharmacist and said that she got a shingle's like rash on her neck. At the time of the report, the patient's outcome was unknown. It was reported that an unspecified treatment was given for the adverse event. This is one of several reports from the same source. Additional information has been requested.
Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine; Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine; inappropriate route of administration; Urticaria; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4506964 (Genentech).  A 76 year-old male patient received bnt162b2 (BNT162B2), oral (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; BENADRYL; ALLEGRA. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "inappropriate route of administration"; URTICARIA (non-serious), outcome "recovered", described as "Urticaria". Therapeutic measures were taken as a result of urticaria.  Additional information: On unknown date, patient started therapy for Urticaria.  The lot number for bnt162b2 was not provided and will be requested during follow up.
High fever( 103 )body aches headache for over 24 hours  Tylenol only brought fever down to 100.9 This lasted from 3:30 am on 4/2 until 9:00 am on 4/3  I currently still have a low grade fever of 99.7 but my headache and body ache are feeling better now
Pt received the PneumoVax on 11/10/03. On 11/11/03 she noted redness, swelling and warmth, and pain at injection site. Took Benadryl with some relief. Seen at Dr's office on 11/12. Examined by CNP and Dr. Objective signs showed left arm erythema without induration 3/4 of deltoid region, tender to touch, mildly warm. Treatment included Benadryl for 2 days, ice packs and avoid PneumoVax in future. 11/14/03 spoke with pt by phone. Arm is much improved.
Significant reaction to flu shot taken 11/13/2001. Area around injection site had fist sized raised, red, swelling and was extremely hot to the touch, as well as sore, child vomited over 5-6 hours to the point of dehydration, headache and high fever.
Spotting ... my period is not due until May 3rd and I never spot in between cycles
PT FAINTED AND FELL OFF CHAIR AFTER GETTING THE VACCINE. SHE HIT HER HEAD, SHE WENT TO THE ER. SHE WAS DISCHARGED ON THE SAME DAY. MD DIDN'T NEED TO DO A CT SCAN ON HER
Client called stating site of vaccination for flu shot on 10/12/09 (right deltoid) still hurts. Explained pain started right after shot given. Over next couple of days a bruise formed "about the size of a 50 cent piece." States bruise resolving and turning yellow but pain continues with that site. Says range of motion to right arm limited due to pain. Instructed client to make appointment with primary care provided and apply warm compress to arm.
aw pain like TMJ pain; painful swollen lymph nodes that were really hard near her left neck; painful swollen lymph nodes that were really hard near her left ear; sore arm; injection site reaction up to her finger tips; dry mouth; Very thirsty; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth), THIRST (Very thirsty) and LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty). On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) and LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear). On an unknown date, the patient experienced PAIN IN JAW (aw pain like TMJ pain). On 10-Feb-2021, INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty) had resolved. At the time of the report, LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck), LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear) and PAIN IN JAW (aw pain like TMJ pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
significant gastro-intestinal bleed.  I noticed blood in my stool the morning following the vaccine.  The bleeding continued for 5 days.
Tightness and burning in chest. Suddenly. 7 hours after injection coughing with small production phlem. 16 hours after burning sinus and eyes and headaches. Benadryl. For 2 hrs hard to breath.
Pediatric patient was given Adult dose of Hepatitis A. Age of patient at time of event: 18 months.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a physician refers to a currently 16 months old female patient with eczema and none Drug reactions/allergies. On 15-FEB-2013, the patient was vaccinated subcutaneously (SQ) with a 0.5 ml dose of M-M-R II lot# H01013, expire date: 17-MAY-2014 and a dose of VARIVAX (Merck), lot# H018015 expire date: 01-OCT-2014 (dose and route not reported). No concomitant medications taken. The physician reported that the patient developed diffuse lymphadenopathy (approximately in February 2013) after administration of M-M-R II and VARIVAX (Merck). On 25-FEB-2013, the patient was evaluated in the office and was found to have post-auricular, anterior cervical, axillary, and inguinal lymphadenopathy. On 25-FEB-2013, complete blood count showed slightly increased neutrophils and decreased lymphocytes. There was no hepatomegaly or splenomegaly. The patient did not receive Treatment. The outcome of outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information is not expected.
weak; extremely tired; chronic headache and after the shot became worse; redness and swollen in the right arm at the injection site; redness and swollen in the right arm at the injection site; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), INJECTION SITE SWELLING (redness and swollen in the right arm at the injection site), INJECTION SITE ERYTHEMA (redness and swollen in the right arm at the injection site), INJECTION SITE PAIN (soreness) and FATIGUE (extremely tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, GABAPENTIN and CALCIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ASTHENIA (weak), FATIGUE (extremely tired) and HEADACHE (chronic headache and after the shot became worse). In January 2021, the patient experienced INJECTION SITE SWELLING (redness and swollen in the right arm at the injection site), INJECTION SITE ERYTHEMA (redness and swollen in the right arm at the injection site) and INJECTION SITE PAIN (soreness). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, ASTHENIA (weak), INJECTION SITE SWELLING (redness and swollen in the right arm at the injection site), INJECTION SITE ERYTHEMA (redness and swollen in the right arm at the injection site), INJECTION SITE PAIN (soreness), FATIGUE (extremely tired) and HEADACHE (chronic headache and after the shot became worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include allergy medication, not otherwise specified.
Severe chilling x 4 hrs, body/muscle aches & migraine type headache x 15 hrs. Severe fatigue- lasting 24hrs
This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 60-year-old female patient who received FLULAVAL (batch number XZ3SP, expiry date 30th June 2015). On 29th October 2014, the patient received FLULAVAL 1 ml. On an unknown date, the dose was an unknown dose. On 29th October 2014, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received: A patient was administered with 1.0 ml of FLULAVAL inadvertently instead of 0.5 ml. No adverse events had occurred as a result
6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired.
Low grade fever 99.3 - 99.5, achiness- all over- site of injection firm, warm, tender