chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling, pain and warmth at injection site. Started to develop the day after injection and worsened until patient presented to the pharmacy today. Patient tried rubbing area to massage out soreness and swelling.
sore arm starting 4/10/21 - at injection site about 50 cent piece size - only when moving arm or brushing up against something, states that feels like immediately after injection but didn't  start until 10 days later, nothing visually wrong
extreme pain in the vaginal area and noticed I had some bumps; vaginal area noticed had some bumps/ herpes; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via unspecified route on right arm single dose for COVID-19 immunisation on 08Apr2021, 05:30 PM, at 20-year-old. Medical history included: allergies: sulfamethoxazole, trimethoprim (BACTRIM). Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) on right arm for COVID-19 immunization on 20Mar2021, 10:30 AM, at 20-year-old. Two days after having second shot (10Apr2021, 08:00 PM), the patient started to experience extreme pain in the vaginal area and noticed had some bumps. The patient went to the hospital and the doctors believed it to be herpes. No test results have not come back yet. They Believed the virus had been asymptomatic prior and getting the vaccine triggered an outbreak. Emergency room/department or urgent care visited and was reported as hospitalized. Treatment received included: antiviral medication and pain medications. Outcome of the events was not resolved.
2-3 days p/inject & for several days pt exp nausea, aches & pains & fever; This resulted in time loss from work; pt was sick from 14NOV93 - 17NOV93;
Flu  symptoms; Eye discharge; Sleepiness; Sinus congestion; Horse voice; Sneezing; Coughing; Mild fever 102 F; Headache; Lack of appetite; This spontaneous case was received on 14-Dec-2021 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW21-06120) and concerned a 56-year-old, male patient.  The patient's medical history included COVID-19 virus infection in Nov-2021, from which he fully recovered. The patient's concomitant medications were not reported.  On 10-Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml; route of administration, anatomical location: not reported) to prevent influenza. The batch number reported was 308439.  On 11-Dec-2021, 24 hours after receiving Flucelvax Quadrivalent the patient experienced flu symptoms, eye discharge, mild fever, headache, coughing, sneezing, hoarse voice. The patient reported having severe sinus congestion, mild fever 38.9 Celsius degrees, lack of appetite and sleepiness. Before taking influenza vaccine, the patient had fully recovered from COVID-19 virus infection. The patient stated that he plans on reaching out to healthcare professional (HC) to take a flu test to see if he has the flu. By the time of initial reporting, the patient has not been diagnosed with flu. The patient received Theraflu (dextromethorphan hydrobromide, paracetamol, pseudoephedrine hydrochloride), as corrective treatment for his symptoms.  At the time of initial reporting, on 14-Dec-2021, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 56-year-old patient experienced influenza like illness, eye discharge, sleepiness, sinus congestion, dysphonia, sneezing, coughing, pyrexia, headache, and decreased appetite one day after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.; Sender's Comments: A 56-year-old patient experienced influenza like illness, eye discharge, sleepiness, sinus congestion, dysphonia, sneezing, coughing, pyrexia, headache, and decreased appetite one day after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.
I woke up with cramping in my hands, my knuckles in my hands felt stiff achy with joint pain. That lasted about 3 months and then went away. And I haven't had it since.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Additional Details: Tingling in finger tips of vaccinated arm, moved to other hand as well. Pt given benadryl and was feeling better. At home symptoms continued and pt took more benadryl.  At home had slight increase in HR, tinitus at bedtime, chest tightness and rash on both arms and neck.  Pt called PCP and was instructed if symptoms worsened to go to ER. Pt has f/u with PCP next week. As of today, pt has not been seen in ER, but continues to self medicate with benadryl.
patient administered Moderna as 2nd dose in the series instead of Pfizer. Discussed current CDC recommendations that patients should not be administered mixed series  however repeating dose is not recommended at this time.
Extreme shivering, to the point of being unable to walk safely. Fever spiked to 104.3 with naproxen already on board. Tylenol brought it down to the 102 range. Body aches, continual headache, shortness of breath.
Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better.  14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.
Grapefruit sized swollen and red and itchy welt at the injection site.  It grew and got worse for two days.  The 3rd day was the worst.  I still have effects 5 days later but symptoms are starting to subside  I'm also very very very fatigued, and I get chills.  I keep taking my temp and it ranges around 98.9-99.3   I have had to take naps in the middle of the work day
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this Unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting "Whoozy", Chills, INjectin site pain, Red blotchiness on abdomen, fatigue, weakness Narrative:
Patient presented to immunization clinic for asplenia vaccinations on 2/22/21.  Pt rcvd PPSV23 via  SubQ to Left arm. On 2/23/21 pt reported having chills, body aches, and shivers. Reported redness and some swelling to LUA where PPSV23 was administered. Pt's temp increased to 101.3 in the middle of the night. Pt reported going to local hospital for evaluation on 2/24/21. Pt is currently (2/24/21) admitted to local hospital and seeking treatment for cellulitis of L arm. Pt is being treated with ABX and antipyretics.
Slept around 20+ hours , just couldn?t stay awake Hot then cold  Broke out in sweat Headache Have a Covid arm was told by pharmacist yesterday
My arm was sore a day after my last vaccine, then faded away as it did with my first two injections. It returned two to three weeks later and remains unusually sore, stiff and painful in my shoulder.
Patient's (R) arm swelled from below elbow up to shoulder. Swelling started a couple of hours after shot. Patient has been taking TYLENOL and putting heat on it.
Patient with 3 COVID vaccines who admitted with complications r/t COVID. Provider d/c note "77 y/o female with history of COPD and Hypertension that presents following recent hospitalization for hypoxemia on 8/19. Bronchoscopy and subsequent BAL demonstrated aspergillus antigen. Culture from lavage showed stenotrophomonas, pseudomonas putida, candida, aspergillus. Patient admitted here on 9/1 for persistent hypoxemia found to be COVID positive, with symptoms starting on 8/30. Imaging significant for CT chest showing stable pulmonic nodules w/ new wedge-shaped atelectatic consolidation & traction bronchiectasis. Patient received seven days of Levaquin therapy, completed a remdesivir course, and was on prednisone 40mg day. Voriconazole for aspergillus also started. Hospital Course: No notes on file. These were her acute medical issues addressed: Acute on chronic hypercapnic, hypoxic respiratory failure: likely new baseline- likely due to acute COVID-19 infection, chronic mucus plugging, suspected Stenotrophomonas, Pseudomonas pneumonia- seen by Pulmonary team. Supplement oxygen with goal SpO2 of 88-92%- aggressive pulmonary toileting- completed 7 days of prednisone and Levaquin- completed Remdesivir treatment. Pulmonary Aspergillosis- continue voriconazole. Total of 3 months: thru 12/5/22- 1 3 beta glucan, aspergillosis galactomannan negative- will need infectious disease clinic follow-up in 4-6 weeks post discharge- will require CMP, complete blood count, voriconazole level around 10/7. Tobacco dependence- nicotine patch- smoking cessation counseling given. Hypertension- Aldactone, Lasix- Held lisinopril for now. Resume if hypertensive. Mild cognitive impairment. Code status: Do not resuscitate DNI. Discharged in frail condition, to local center for further rehab".
Received 2nd set of vaxs on 30DEC94 at 9:30AM; baby found dead by parents at 0730AM on 31DEC94; has twin sibling who also received same vaxs at same time--sibling is fine;
About 17 minutes after the vaccine, I started to feel light headed and dizzy. I flagged the nurse and told her that I shouldn't leave the location yet because I could feel that my blood pressure had gone up. An ER nurse came over and they decided to keep me for an hour. I went for a short walk with one of the nurses and I felt okay. I was well enough to drive the hour drive home. I had a follow up, with my doctor, a week after the vaccine. I asked her if I should increase my dosage and she said yes. So, by the time I went to get my second vaccine, I doubled on my lisinopril. My blood pressure still went up, but nowhere near as bad as after the first dose.
Unusual & increasing pain in upper arm with increasingly limited range of motion continuing to this date with some improvement.
Brain fog is so bad i can't remember things anymore prior to the shot I was clear thinking and never forgot a thing. This has severely impacted my day-to-day life. I can't find a normal job due to the fact that my memory is basically nonexistent.   My periods have also been affected. I was regular every 4 weeks, lasting no more than 4 days with light to moderate flow, now I'm bleeding heavily, and lasting sometimes 2 weeks with excruciating cramping for the full duration.  Also, i was also very energetic, now i struggle to climb a set of stairs without wanting to pass out due to feeling short of breath.
Pt received vaccine and roughly 5 mins post vaccination pt became delirious and then fainted. Pt was put supine on ground to prevent falling. 911 was dialed. Pt came to roughly 30 seconds after fainting. Paramedics came and treated the pt 10 mins after episode.
Local reaction to right thigh with 3.5cm X 2cm redness, 2cm X 1cm induration. Non-tender, no fever and no treatment.
This spontaneous, non-valid report was received from an immunization official and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX one dose each, lot # N020016, expiration date 17-JUL-2019 (exact dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -3.05 degrees Celsius for 4 hours 25 minutes. Digital Data Logger was involved. There was a previous excursion of -11.52 degrees Celsius for 1 hour reported. This report is considered non-valid due to lack of patients identifiers.
arm is still killing him / arm pain (at the injection site / it hurts; he raises his arm to shoulder level or above it hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (Reeceived flu vaccine on unknown date), Pneumonia vaccine (Received Pneumonia vaccine on unknown date) and Covid vaccine (Received covid vaccine on unknown date).   On 13th July 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 14th July 2021, 1 days after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   The reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the dose Flu vaccine,Pneumonia vaccine and Covid vaccine in past. The patient received the 1st dose of Shingrix in the top of the left arm (deltoid) and the day after the vaccination patient had arm pain (at the injection site) The patient stated it had been over a month and his arm was still killing him. The patient stated that the arm pain was not affecting his mobility. The patient stated that he was able to move the arm but he indicated that if he raised his arm to shoulder level or above it hurt. The patient stated that tried treating it with ice and he had tried treating it with heat and the pain would go away for about an hour and a half but then it returns. The patient stated that he would not be receiving Shingrix shot 2. The reporter stated that the injection site pain and pain in arm was related to the Shingrix use. The patient did not have the lot number/expiration date of the vaccine however he did provide the name and address of the pharmacy where it was administered. The reporter consented to follow up.
PAIN IN FEET COULD NOT BEAR WEIGHT ORTHOPEDIC SHOES RIGHT SIDE GOT BETTER LEFT SIDE PROCEEDED TO GET WORSE FREQUENT HEADACHE FATIGUE
1. HEADACHES 2. COLD/ FLU SYMPTOMS 3. NO ENERGY  4. BLOODY NOSE 5. HEART PAIN 6. SPINE PAIN 7.  MENTAL CONFUSION 8. FORGETFULNESS ALL THIS IS A RESULT ACCURING AFTER RECIVING THE VACCINE.  MY HEAD IS ALWAYS HURTING AND I HAVE NO ENERGY TO GET OUT OF BED I DONT WANT TO TAKE ANOTHER DOSE.,
The patient was out of work for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (The patient was out of work for 4 days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMPAIRED WORK ABILITY (The patient was out of work for 4 days). At the time of the report, IMPAIRED WORK ABILITY (The patient was out of work for 4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter. The patient's weight was provided as 180.   This case was linked to MOD-2021-123321, MOD-2022-460419 (Patient Link).
The patient experienced tingling and pins and needles pain throughout her entire body about 10 hours after receiving the vaccine.
Pharmacy was doing a flu clinic on 10/31/18. The patient got a flu shot (FLUARIX) and upon injecting and taking needle out, blood came out. More than normal. Gauze was put on to stop bleeding. A band aid was put on. A lump started to form at injection site. It was hard. Ice was applied for about 5 minutes. Patient was doing ok. No other symptoms. Patient was monitored for about 10-15 minutes. Patient was notified to continue to monitor for worsening lump (it was smaller than the bandaid) and with other symptoms such as dizziness to contact doctor. When patient left the hard lump was still there, bleeding had stopped, but hard lump wasn't getting any bigger.  Will be following up with patient with phone call in a couple hours to see how patient is doing.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/21 2nd dose01/13/21 Diagnosed covid positive:08/27/21 Symptom onset:08/24/21 Exposure:Home Symptoms:muscle aches, sore throat, sinus pain
Urticarial rash, angioedema of eyes & mouth; hospitalized x 2 days; no bronchospasm or resp distress;
(L) shoulder swelling 10cm (asthmatic). Erythema. Patient give MOTRIN.
Redness to injection site and small in duration of 1 cm x 1 cm with fever.
This spontaneous report as received from a pharmacy student refers to a 66 year old female patient with unspecified cholesterol condition. The patient had no drug reaction/allergies. On 09-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as J008736 which was not valid for ZOSTAVAX, expiration date 16-JAN-2015, once, subcutaneously in the left arm (dose and strength not reported. Concomitant therapies included simvastatin (manufacture unknown). The pharmacy student stated that the patient who experienced adverse events after receiving ZOSTAVAX injection on 09-JUN-2014. The patient reported to pharmacy student that she developed injection site reaction in left arm, raised and hard bilateral lymph nodes in a swollen neck, and a itchy, red, and sore in the scalp on head since unspecified date (in approximately June 2014). The pharmacy student stated that it was confirmed with the patient over the phone that this scalp was not a rash. The patient did not seek medical attention. The outcome of the events was unknown. Additional information has been requested.
headaches; pain; This case was reported by a physician via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain. On 25th October 2020, the patient experienced headache. On 29th October 2020, the outcome of the headache and pain were recovered/resolved.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headaches and pain during 3 to 4 days after the adminsitration of Shingrix.  The reporter consent to follow up.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (5 patients dosed with particle in vials) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by the reporter. On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 patients dosed with particle in vials). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (5 patients dosed with particle in vials) 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. This case was linked to MOD-2021-206071.
Expired ROTATEQ was administered; no additional AE; This initial spontaneous report was from a medical assistant regarding a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1691140, 2 milliliter, oral, for prophylaxis (strength was not reported). The product had no prior temperature excursions. No additional events reported.
This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date, the patient was on ROTATEQ (dose, frequency, route, lot number and expiry date not reported) for propylaxis. The patient inadvertently received a fourth dose ROTATEQ on an unspecified date 6 months after receiving the 3rd dose of ROTATEQ VIAL. No adverse effect reported.   Additional information has been requested.
Immediately after receiving vaccine became lightheaded/dizzy, decrease hearing/vision numbness of extremities. 3 days after numbness of feet, dizziness. Difficulty breathing for 1 week. States constantly feeling like having asthma attack.
14 yr old male attendee was given the child's dose of PFizer due to him stepping in front of the 8 yr old sibling also in the room. Both have 'special needs' instructions and with the 3rd younger sibling created a cacophony enough, the mistake happened.  The team is going to rearrange their process to separate siblings next time. No Adverse reaction noted.
Patient reported to pharmacist (3 days after receiving). Revealed slightly swollen and red area to pharmacist. Patient states slightly warm to touch. Advised patient to monitor for improvement.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-125312 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-125312:First dose case