chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown demography and reported that 3-4 drops had leaked out of the syringe but the patient had gotten more than half of the vaccine, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Typhoid VI Polysaccharide Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to vaccine underdose. It was also case of syringe issue. (It was reported that 3-4 drops had leaked out of the syringe but the patient had gotten more than half of the vaccine). It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Noticed raise red marking approximately 2 inches in diameter on the morning of 3/30, as well as it being itchy and hot to the touch. The next day 3/31 it approximately doubled in size when checked in the evening with the same symptoms along with being uncomfortable. There are also on and off feelings of numbness and pin and needle feelings in the area
On-going pain, redness, itching and burning sensation at the injection site as well as stiffness, discomfort, tingling, mild numbness and joint pain, and headache from the day of injection, at the time of writing this report including the days in between injection and reporting.  Initial swelling an hour after injection on 3/11/21 was the diameter of a quarter; swelling as of 3/15/21 is approximately 4.5 inches in diameter. The surface temperature of the injection site remains approximately 98.1 degrees.  In addition, I am experiencing noticeable numbness and tingling on the left side of my body including facial muscles surround eye, mid face, left hand radiating out to all 4 fingers, left thigh, and left calf. I am experiencing joint and muscle pain on the left side of my neck, left shoulder, left upper arm, left elbow, left hip, knee and ankle.
Diarrhea about 9 times a couple of hours after I got home til midnight...36 hours later woke up with fever and sweaty at 2 a.m. but felt better by 10 am. Sore arm for 3 days.
Headache; Fever; Chills; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and RASH (Rash). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment given
Beginning 9/16/18 patients whole body turned red (not hives). Patient began sweating profusely and her skin felt hot. Her scalp was burning. She claimed she looked sunburnt. Her hair began shedding in chunks and has since. She claims her sleep pattern has been interrupted. Patient feels off.
muscle aches/joint aches ongoing,  intermittent tinnitus,  shortness of breath/ difficulty running and exercising.  trouble with critical thinking/problem solving/ memory problems
Vaccine received at 10 AM on 1/28/21.  No symptoms that day, but upon awakening at 8 am on 1/29/21, I was experiencing chills, fever of 100.9, pain at the injection site, body aches and fatigue.  It literally feels exactly like I did when I had COVID.
Five red macules at injection site about 1cm in diameter with surrounding erythema about 15 cm up and down right deltoid area; activated axillary lymph node. Diagnosed kephalepan and warm compresses.
Presented to hospital on 1/5 after 4 days of weakness and nonproductive cough with COVID-19 pneumonia. After 2 days became hypoxic and started on remedesivir and dexamethasone. supplemental O2 up to 6.5 Liters.  concern for aspiration put on thickened liquid diet but eating minimally with dehydration. NG tube attempted unsuccessfully.  Sodium trending up, IV fluids started. Noted confusion and encephalopathy. Given lasix for possible fluid overload Continued to decline. 1/16 family elected comfort measures.
Pt presented at Medical Center on 10/02/2009 with bilateral weakness. Patient was found to have bilateral/symmetrical weakness with decreased deep tendon reflexes. Patient was diagnosed with GBS.
On 2/3/21, day nine following the first dose of the Pfizer Covid vaccine, the vaccination site was itchy.  The following day there was a red rash at the site.  The rash is circular and about four inches long and two inches wide.  It is not a raised rash.  Today, 2/10, the redness and outline of the rash appears to be fading.
Patient said we she went home from shot that her heart was racing for a few seconds. She does not normally experience this. She told me after administration of second shot.
Severe local reaction (cellulitis); 11x5 inches of erythema and induration. Treatment given: Benadryl syrup 2tsp down to 1tsp and Hydrocortisone cream 25%.
Very  painful/swollen around injection site, clear drainage from site, and extreme itchiness.
pt sent from hospital ED for pneumonia due to COVID; Initially in ED pt c/o headache, myalgias, dizziness, diarrhea, cough with increasing SOB; 84% O2 saturation on RA; placed on NRB with O2 saturation at 92%; pt positive for COVID; UTI; given Decadron and ABX; eventually required Vapotherm and NRB due to worsening respiratory status; pt's condition deteriorated and she was transitioned to comfort measures; she passed away in the hospital
No Adverse Effects.   Resident received expired Moderna Vaccine, expired on 10/13/2021
Flu-like feeling; Body aches; Major headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041c21A and 007c21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches) had resolved. Not Provided          Patient height was reported was 5.10 inches  Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-415874 (Patient Link).
T/C from mom 8/13/03 1:30 pm, Rt arm where 2 shots were given, is swollen from top of shoulder to elbow, red and hot to touch. No fever. Tylenol given over last night 8/12/03, swelling, noted this am, painful for child. 8/25/03 T/C to mom, did not seek PMD. Gave Motrin x 1 1/2 days and child is fine now.
Severe rash, moderate/severe erythema, moderate itching, burning.  (Complained of mild shortness of breath, none noticed, O2 sats 99% room air.) Symptoms were severe within 15 minutes of administration, immediately sent to our ER. Treatment I.V. access, 25 mg. Benadryl IM, Benadryl 25 mg. IVP.  12/14/09 MR received for DOS 11/18/09. Pt c/o rash, SOB, pruritus. Tx: Benadryl. Dx: reaction to swine flu nasal spray. Pt discharged home in good condition.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient states he got dizzy and suddenly blacked out. He fell over from his chair, shaking, and sweating. We helped him up and he being responsive again immediately. Had patient sit at the pharmacy for 30-40 minutes to monitor patient. Had him drink water and cranberry juice and he states that it helped his lightheadedness go away. He became fine after 30-40 mins of observation. I will be calling patient back the next day to check up on him
Redness under injection site with swollen bump, itchy and tender. States initial tenderness resolved after a couple days then arose one week later.  Using Hydrocortisone on site.
Patient came to the COVID-19 vaccine clinic  and inadvertently received a 22 mcg dose of the Pfizer COVID-19 vaccine. I spoke to mom who tells me she completed the 15 min observation period without any unusual symptoms. Mom was counseled to monitor patients symptoms over the next 7 days and report any concerns to her pediatrician or if more serious to go to the ED.
pt recvd vax 31OCT95 lt arm;pt became nauseated later that day;became red around inj site the next AM;warm & perspiring most of day 2NOV95;had temp 100-nausea, red blotches down most of lt arm
It was reported post vaccine's pt developed a low grade fever of 99F and redness to the R upper thigh.
8 days later, my left arm became swollen, red, and very hot. Plus, I had pain all the way down to my finger tips, like bad cramping.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included CIDP. Concomitant products included LEVOTHYROXINE, ALPRAZOLAM and OMEPRAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications include Supplements.  Patient got a steroid shot for the tendinitis in her elbow 2 hours prior to second dose of Moderna COVID-19 vaccine.   This case was linked to MOD-2021-286530 (Patient Link).
Flu-like symptoms; Pain in the arm; Feeling very tired; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in the arm) and FATIGUE (Feeling very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in the arm) and FATIGUE (Feeling very tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in the arm) and FATIGUE (Feeling very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported. On 16-FEB-2021, the patient tested for IgG and IgM through fast RNA COVID qualitative NAAT (nucleic acid amplification test). The test results stated IgG and IgM antibodies were not detected.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Additional initial document received.
c/o arm hurting, low grade fever cont to inc to 105, vomiting; gave APAP, fever stayed 105, cool baths, next day t102 stayed 24 hrs felt better Friday;
Pt presented with a rash at the site of injection given at pharmacy on 02/25/22. Reports increase in erythema, warmth, tender to touch .
I got the shot on 4/6/21 and on 4/10/21, I experienced brain fog, dizziness and a rash on my left side, right below my left breast. Now, as of 5/8/21, I have developed ringing in both ears, which I never had before.
Significant ringing  in my head (Tinnitus) began within a couple of days of receiving the vaccine.   I delayed getting the second dose by a month hoping that it would subside and out of fear that the second dose would make it worse.  I decided to get the second dose on 8-4-21.  Within 2-3 days, the ringing intensified by a factor of approximately 3X.  Big mistake but stopping short of being fully vaccinated would not permit me to enjoy unhindered travel and avoid other restrictions.
Pt has had increasing shortness of breath and cough for a week.  Admitted with COVID pneumonia.
fever, nausea, headache, weakness, dizziness, leg cramps, pins, and needles in legs, feet and hands; will follow up with my Dr.
achy; felt unwell; diarrhea (her stomach was not right); malaise; chills; felt like the flu; really fatigued; This is a spontaneous report received from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), intramuscular in left arm on 13Jan2021 at 11:30 (at the age of 71-years-old) as first dose, single for COVID-19 immunization. The patient received his second dose of bnt12b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9810) on 3Feb2021 for COVID-19 immunization.  Medical history included hip bursitis on 21Dec2020. She had a cortisone shot in her hip before to treat her hip bursitis. Patient family history relevant to AE was reported as none. Concomitant medications were not reported. Patient did not receive any other vaccine 4 weeks prior to the vaccine and did not receive any other vaccine on the same date of Pfizer vaccine. On an unspecified date in Jan2021, the patient experienced diarrhea (her stomach was not right), malaise, chills, felt like the flu and really fatigued and on an unspecified date, she felt unwell and achy. She was about 75-80 percent better with the symptoms and stated that the diarrhea resolved on Friday. Patient reported that she went to see her doctor about it and they did blood tests and the blood tests did not show anything significant. She was going back to the physician tomorrow 09Feb2021. The patient underwent lab tests and procedures which included blood test: negative on 29Jan2021. Patient reported that she was about 75-80 percent better with the symptoms Patient reported that while in the line for her second dose she overheard someone reading the possible side effects of vaccine, she realized that she had a lot of the symptoms. Patient reported that she had symptoms after getting her first dose that lasted for 3 weeks. Patient wanted to know if that duration of time was normal and also wanted to know if anyone else reported side effects lasting for 3 weeks. The outcome of diarrhea was recovered on 05Feb2021, outcome of felt unwell and achy was unknown while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Sensitivity to light; Tenderness in lymph nodes in neck and groin; Bad headache; Dizziness; Soreness in right arm; Fatigue; Mild headache; A spontaneous report was received from a nurse who was a 61-year-old female patient who received Moderna's COVID-19 Vaccine, and who experienced soreness in arm, dizziness, fatigue, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin.   The patient's medical history was not provided. Concomitant product included Effexor and Sertraline for depression.  On 30-Dec-2020, approximately 24 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   A nurse reported that she received the Moderna vaccine on 30-Dec-2020. On 31-Dec-2020, she experienced soreness in her arm, dizziness, fatigue and a mild headache. She stated that these symptoms improved over the next two days but then on 03-Jan-2021, she experienced a bad headache, light sensitivity and lymph node tenderness in the neck and groin. She stated that she was feeling better on 04-Jan-2021 and was no longer taking any pain-relieving medications. The patient was concerned about the duration and intensity of her symptoms and she was also concerned because she stated that she did not usually get headaches. Additionally, she wanted to know if she should get the second dose because she understood that the second dose may cause more side effects that the first dose.   Treatment for the event included paracetamol, plenty of water and rest.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events soreness in arm, dizziness, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin was recovered and of event fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient called pharmacy at 7:00 am on 1/22/2021 stating she has had hives and severe redness / swollen at injection site I asked if she has spoken to physician she said no has taken Benadryl and Tylenol. Told her I would make report and go to doctor if gets worse.
1155: Numbness and tingling at injection site that spread to the left side of neck and down to left elbow. "Feeling warmth under skin". Lethargic. 1200: Numbness in left finger tips. Left arm "aches", pain 4/10 on 10 point scale. Full range of motion present. 1211 BP 176/107, pulse 92. 1214 BP 178/106 pulse 89. 1218 HMS notified. Employee sent out with accident referral packet.
unsteadiness in walking; nausea; extraordinary fatigue; mobility is dramatically reduced; hands tremble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "recovered", described as "unsteadiness in walking"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; FATIGUE (non-serious), outcome "recovered", described as "extraordinary fatigue"; MOBILITY DECREASED (non-serious), outcome "recovered", described as "mobility is dramatically reduced"; TREMOR (non-serious), outcome "recovered", described as "hands tremble".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
2/28.. 6pm...left arm pain 3/1 10am...chills,no temp, drinking lots of water, lathargic 2pm...chills,noxious,drinking lots of water, lathargic 7pm..chills, noxious, temp 100.3, drinking lots water, larthargic 10 pm.. chills, temp 100.6, tickle cough 3/2 11 am..  no chills, temp 98.6, normal feeling, tickle cough
25Oct90 pt vax w/ MMR; 06Feb91 inadvertently admin 2nd dose.  No noted problems.
When she recieved the flu shot, she thought nothing of it. After 2 days her arm became very painful. For the last 3 weeks she had lots of pain and had difficulty with range of motion, lifting arm over her head, undressing and sleeping as it would hurt when she rolled over on the arm. She went to a physician who said the shot was not properly placed, thinking the nurse must have hit a nerve. The physician prescribed time, aspirin and tylenol. As of 10/27/09 it was far better.
I had both Pfizer vaccinations the 2nd on 4-7-2021 and got the varriant infection for covid and lost my sense of smell and taste
Mild headache; Tips of ears hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and ear pain. On an unknown date, the outcome of the headache and ear pain were unknown.   It was unknown if the reporter considered the headache and ear pain to be related to Shingrix.     Additional Information: GSK Receipt date: 14-Feb-2023. Reporter's Comment: The case was reported by patient herself. The patient received the 1st dose of Shingrix, at the end of January 2023, she had a mild headache and the tips of her ears hurt a little. The patient disconnected the call before they could obtain her DOB, ask for consent to follow up with HCP,  or any other information about her 1st dose of Shingrix. The reporter did not consent to follow-up. The consent to follow up with HCP not obtained.
This case was reported by a nurse via sales rep and described the occurrence of generalized urticarial in a 19-year-old male patient who received BEXSERO (batch number 156801A, expiry date August 2017). On 10th November 2016, the patient received the 1st dose of BEXSERO 0.5 ml. On 11th November 2016, 1 days after receiving BEXSERO, the patient experienced generalized urticarial. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized urticaria was unknown. The reporter considered the generalized urticarial to be almost certainly related to BEXSERO. Additional details were provided as follows: Concurrent medical conditions was reported as no known allergies. The patient called the pediatrician because he had hives all over his body. He went to an Urgent Care and was given oral BENADRYL.
Left shoulder began swelling approximately 3 hours after injection,  swelling continued down the arm and caused numbness in the forearm and hand.  The upper arm was hot to the touch and redness was noted.  Severe left shoulder pain with the inability to raise the arm to 90 degrees and cannot rotate the forearm.  This is currently continuing and I am not about 28 hours post-injection.  Initially, the pain was a 10/10 it is now an 8/10.
Severe language delay and hearing sensitivity after vaccines with MMR and Hep-B. Child is now Autistic. Received, ABA, Speech and Occupational therapy. Leaky Gut Syndrome. On annual report received 04/25/2003 mother states, "he is autistic - he has high levels of mercury and lead in his gut. His vaccines contained thermirasol."
Hours after the second vaccine there was a constant adrenaline rush all day and all night.  Took to walk in and put on propranolol to stop adrenaline and slow her heart rate.  Severe anxiety attacks with panic.  Has not slept since the second vaccine on 04/24/2021.
1/16/07 6 pm arm sore. 1/16/07 7pm felt sick, chills, light headed, no appetite, "could not get warm". Chills, Temp 102F, drank tea began sweating. 1/17/07 went to hospital early morning. 1/17/07 observed red patch 3.5x2 inch warm to touch, tender when touch.
Fever, chills, malaise, body aches, nausea, headache, all lasting 24 hours. Treated with NSAIDs, resolved after 24 hours.