chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse reaction that she was experiencing after her first dose; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose). At the time of the report, ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Noticed red bumps on abdomen on Mon. night by dad. Tues. morning noticed bumps on face. Called last pm 10/09/2002 Mom thought the bumps would go away. Instructed to bring in this am 10/10/2002. Rash on trunk, legs, one on ear no fever.
Left arm became red, itchy, swollen and "hot" the following day after administration around 4pm.  Taken to pediatrician and told it is cellulitis and prescribed Augmentin.
Severe swelling and tightness of right arm. Started 10/02/2002. Still swollen on 10/04/2002
Two night after receiving my 4th vaccine, I experienced a rapid heart beat. While I'm asleep it goes down rather rapidly and then it goes up to over 100.  I experienced this with my 2nd vaccine.  I was alerted to the issue with my Fitbit.  I will get a echocardiogram per instructions  by my doctor. I tested positive for Covid 19 in December 2021. I did a home test and it was negative. In January 2022, I got a PCR test and it was positive.
She felt faint and had to collapse on the floor. The nurse asked her to come in to the room but she was unable to. The nurse came out and gave her apple juice.
Information has been received from a registered nurse concerning a patient who in approximately April 2008 ("in the past few weeks"), was vaccinated orally with a 2 ml dose of ROTATEQ.  In approximately April 2008, within one week of vaccination, the patient had blood in their stools.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Upon internal review "blood in their stools" was considered an other medically important event (OME).  This is one of two reports received from the same source.  Additional information has been requested.
On 04/04/2002 hives started at injection site and spread over arm. took ataRAX. lasted three days. Gran mal seizure on 04/10 and saw neurologist. Had stopped seizure medication seven days before. The neurologist stated that "could be from vaccine or stopping the seizure medication."
11/18 developed headache 11/19 start having squeezing heart pain around 1pm. 11/21 went to ER early in the morning for the same pain. Ran cardiac labs and everything appeared normal. 12/17 returned to ER with chest pain and SOB. Was admitted to hospital. Stayed in hospital 12/17-12/19. Echocardiogram showed pericardial effusion and pericarditis. Discharged with 3 meds to resolve fluid. With follow up visit this week. Still having sharp chest pains and shortness.  Also began having bladder issues after the vaccination and now have a bladder infection I am on antibiotics for.  11/21 swollen lymph nodes under each arm and in groin. Knees also began hurting.
Approximately 24 hours after receiving the vaccine I began having an elevated resting heart rate. My normal is 65-70. At 11am on 8/27 my fit alerted that my HR was 127 (I was not being active, I had been sitting on my porch for about 30 min). I checked my BP and it was 154/150.  Since then my HR has fluctuated from 90-156 and my BP  between 93/73 to  154/150. I also had a fever of 101.3 beginning  around 9:00pm  on 8/27 it  went down with Tylenol.
The patient developed covid flu symptoms included, fever, chills, swollen limbs, achy, coughing up mucus and had swollen lymph nodes under her arms and breast.  Pt was breast feeding and her 2 month old baby developed these same symptoms as well as difficulty breathing due to the congestion.  She took her baby to her Pediatrician and was told to use the nose sucker and saline solution only.  Mother and child were both sick for over 3 weeks.  Pt was forced to get 2nd vax on October 1st, 2021 (IM Right Arm- Lot # 30130B7) were she was sick for about 3 or 4 more days.  Mother states her milk supply dropped to about 1/3 of normal supply and is still not back to normal.  Both Mother and child are better now.
double vision; rash down to the elbow on arm injection received on; This case was reported by a pharmacist via call center representative and described the occurrence of double vision in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) 5 ml. On 28th January 2020, 2 days after receiving Shingrix, the patient experienced double vision and rash. On an unknown date, the outcome of the double vision and rash were unknown.   It was unknown if the reporter considered the double vision and rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced double vision and a rash down on her elbow in the arm where she received her injection after receiving Shingrix vaccine. The reporter consented for follow up.
Lump at Collar Bone; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Lump at Collar Bone) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NODULE (Lump at Collar Bone). At the time of the report, NODULE (Lump at Collar Bone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a positive PAP smear. This was the first time the patient had a PAP test conducted. The outcome was not reported. Additional information has been requested.
IM shot given at 2:52.  Took 4-5 alcohol prep pads to stop continuous blood dribbling.  Within 30 seconds, patient showed a slight bump at site of injection.  Just as the bleeding concluded and I was about to apply bandaid, patient blacked out, eyes began to flutter, body straighten and began to slouch in chair as I held her up, and fingers fluttered a bit as well.  Patient came about with 30 seconds, moderate hyperventilating, and with clammy sweat, unaware of where abouts.  Monitored patient for 30 minutes, but she did go home after re-attempting to work once again (got a ride from family).
Sudden burning, warming, tingling sensation all over body, especially in extremities. Started 5 minutes after injection and lasted about 1 hour.
Tenderness and 1-2 cm round nodule at Anthrax vaccination site.
no local reaction no fever/chills & both swollen knees; some nausea but no vomiting;
Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe  lower back pain
Pt vaccinated with Heptavax-B in 1987 developed pneumonia & bronchial spasms. On 8NOV90 developed fatigue, malaise, a fever, chills, sensation of warmth, irritability, anorexia,headache,dizziness,coughing,flushing,urinary freq & dysuria.
Client observed vomiting .  When asked, client voiced that she had same reaction with first dose and had notified her physician.  Client seen and assessed by EMT and V/S are B/P 214/148, HR 86, O2 97%.  Client advised to go to ER but declined and voiced that her husband would take her.
Fever Tm104.9 today; generalized tonic-clonic seizure lasting <5minutes; ended spontaneously; seen in emergency room and discharged home.  11/28/06 Received medical records from ER which reveal patient presented with fever 104.9 & seizure lasting approx 30 sec then was post ictal.  When examined in ER she had recovered & had no further seizure activity & after observation was d/c to home. Birth HX: WNL.  delivered full term via c section, 7 lbs. Normal development.  No hx of seizures in patient or family members. Final DX: febrile seizure w/o evidence of infection./ss
Episodes of heart palpitations and mild light headed during first two days after shot.  These episodes stopped about two days after the shot.  Foot and lower leg pain and foot discoloration started about 6 hours after second shot.  Toes turned pinkish-purple, bottom of feet would turn bluish-purple.  Improved when elevating feet.  The discoloration has improved but not completely gone.  Foot pain continues only slightly improved 5 months later.  I have never had any prior issue with feet.  I go barefoot a lot and know this was not happening prior to the second shot.
Chills; Fever; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EL9265) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing), notes: Eliquis: been taking this for years, she has a pacemaker. If stopped or ongoing unknown; "Heart medication" (unspecified if ongoing); "plaque" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: COVID in the very beginning. Concomitant medication(s) included: ELIQUIS taken for cardiac disorder; LOSARTAN taken for cardiac disorder; ATORVASTATIN taken for psoriasis. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain.  Additional information: It was reported that the patient had COVID in the very beginning, but then she got all her vaccines. With the last 2 doses of the Pfizer Covid-19 Vaccine she had vomiting. She clarified she just had the last Pfizer Covid-19 Vaccine, Bivalent booster on 01Nov2022. The second to last dose she violently threw up for almost 24 hours with. 04Nov2022 she is so weak, she understands part of it, but does not know anyone else who throws up. She does not know if this is an allergic reaction to the product. She does not know if she can do this again. Since Tuesday, today she is finally back in the real world, she was close to going to the hospital she was so sick. If she didn't have it twice, she would think maybe she had a bug, but it has happened with the last 2 vaccines. They used to tell her in the beginning, the first couple she had the chills and the fever, but she did not have a fever 03Nov2022 and did not have chills. But the extreme vomiting she had. Just talking about this is making her sick. She needs Zofran or something because of how deathly ill she is. She does not get ill from the flu vaccine. With the last 2 doses she had onset of violent retching, vomiting about 8-10 hours after administration that lasted for almost 24 hours. With the first 2 doses she was achy, had chills, fever for about 24 hours. She verified there are no relevant other medical conditions to report. She walks, drives, does her own house, lives alone, watches grandbabies. She is as active as she can be. She verified that there have been no relevant treatments or medical interventions to report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279824 Same patient, different dose, different AE;US-PFIZER INC-202201286340 Same patient, different dose, different AE;
Onset of symptoms 7:05PM: fatigue, fever and chills, headache, muscle and joint pain, and mild soreness at injection site. Went to bed with a mild headache.  9/28/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, diffuse joint pain, moderate soreness, redness, swelling, and itching at injection site, moderate to severe low back pain, moderate to severe knee pain, muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, fever and chills, moderate headache.    9/29/22: Mild muscle, joint, knee, and low back pain. Nausea, restlessness, fatigue, fever, chills and headache resolved. Diarrhea, postnasal drip, and sinus congestion. Mild soreness, redness, and itching at injection site.   9/30/22: Mild muscle, joint, knee, and low back pain. Diarrhea, postnasal drip, and sinus congestion resolved. Mild soreness, redness, and itching at injection site.   10/01/22: Mild muscle, joint, knee, and low back pain. Mild soreness, redness, and itching at injection site.   10/02/22: Mild muscle, joint, knee, and low back pain. Injection site symptoms resolved.  10/03/22: All above symptoms resolved.   10/06/22: Woke at 2:30AM with severe redness, itching, swelling and heat at injection site and surrounding tissue; approximately 4" wide x 5" long surrounding injection site. Began treatment with topical muciprocin.   10/07/22: Mild redness, itching, swelling and heat at injection site and surrounding tissue upon waking until 9PM when symptoms increased to moderate. Applied topical muciprocin.   10/07/22: Mild itching and redness at injection site and surrounding tissue. Applied topical muciprocin.   10/08/22: Mild itching at injection site and surrounding tissue. Applied topical muciprocin.   10/09/22: All symptoms resolved.
Patient was very nervous prior to injection because of Lupus and previous reactions.  Began feeling as though heart was racing and pulse was elevated. Moved to Acute monitoring. 0904- BP 156/88, HR 148, R, 26 SpO2 100. Shaking, tearful, sl red faced. Did not eat prior to vaccine, did take Norvasc.  Has distant Hx of panic attack that felt similar.  0910 - 135/83, 111, 24, 100%. Calmer, no longer crying, shaking decreased, eating crackers and drinking water.   0915 - 128/10, 106, 22, 97%. No visible shaking. Ambulated to BR accompanied. 0923- 130/83, 112, 20, 98% - 0930 -  110, 78, 111 20, 97% - accompanied to car.  Will notify Dr and at next vaccine will request to have in Acute Response area.
My symptoms began on December 14th with diarrhea and fever. I had chills during the night. The next day I had a slight fever, and my back was very hot. The next night I had chills. The following day I had runny nose and sneezing and slight sore throat. These symptoms lasted for 5 days. I took PAXLOVID beginning December 15th. I felt better and tested negative. But three days later I began to feel weird and tested positive again. I then had chills and cold-like symptoms. I also felt lightheaded and had diarrhea.
Ache and pain in the bicep and forearm. Pain got worse after 2nd dose on 1/16/21. No other side effects, just arm pain. It continues today, did not have pain prior to injection.
Shingles (R) arm - acyclovir, antibiotics.  9/28/07 Reviewed hospital medical records which reveal patient experienced rash over right arm & hand.  Had reached into brushpile & received abrasion of right palm.  Next day blister had formed on palm & additional vesicles & erythema formed over her hand.  Seen by PCP & dx w/contact dermatitis.  That evening became restless w/poor sleep.  Next morning large red blisters & erythema were noted over her right hand, arm & shoulder & had fever of 102.  Taken to ER on 8/16, dx w/staph infection, c/s of lesion done, received IV antibiotic in ER & d/c to home on oral antibiotics. Continued to have fever, palm excoriation & pain increased.  Admitted 8/18-8/19/2007.  ID consult done.  Tx w/IV antibiotics & antivirals. FINAL DX: herpes zoster & allergic dermatitis.
Started with pins and needles in my left hand followed by numbness in thumb and index finger and rights side of hand. I spoke to my doctor who advised me to come in to the clinic if it was still numb next Monday 24th May 2021
Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID; Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID; Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01May2021 as dose 1, single (Batch/Lot number: unknown), on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) and on 19Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022, outcome "not recovered", described as "Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 29Mar2023 to 02Apr2023. Clinical course: The patient had no known previous infections.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148313 same patient, different drug/event;
no further adverse event details; he missed the timeframe for the second dose due to insurance issue; This spontaneous report was received from a pharmacist and refers to a 36-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-OCT-2020, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 17-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. He missed the timeframe for the second dose due to an insurance issue. On 17-MAR-2021, the patient got his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not reported), which was outside of the recommended administration schedule. There were no further adverse event details or additional information.
day after shot given, patient developed swelling, and redness about 2 inches below injection site.   this continued for next two days and progressively got warmer to the touch as well.    Patient was advised to visit physician unknown diagnosis/ treatment/ outcome
Patient was administered pediatric dose of Pfizer vaccine at age of 12 by RN.  Patient should have received 12+ dose at this time.  Patient and parent state no observable adverse effects from pediatric dose.  Patient given correct 12+ dose today (12/8/21).  Patient observed with no adverse events after doseage as per protocol.
Patient received Tdap injection on 4/24.  Today, patient has half baseball sized swelling on arm at injection site with tenderness.  Small amount of erythema in shape of bandaid.
Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started. These other symptoms are still present after almost 3 weeks.
Cold; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included ATENOLOL, ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE, CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy) outcome was unknown.
pt was nervous and nauseated.  Pt was asked to continue to sit and sip on water and provided a snack.  after 10 minutes pt left after stating she was feeling better.
This is a spontaneous report from a licensed practical nurse. On an unspecified date, the pt received the 1st dose of Lymerix and a few hours later, the pt stated that he experienced convulsions. Physician stated in medical records that the pt had shakes. Convulsions were not mentioned. The pt took Advil and symptoms were reduced. The most recent information, received on 7/20/99, reports the condition of the pt is resolved.
Left arm immobilized due to painfully soreness and stiffness with nerve in left arm involuntarily jerking.
After receiving Pfizer vaccine, patient reported some lightheaded ness and some chest tightness. B/P 131/95, P 73, R 16. She was given orange juice, cookies and continued to be observed for an additional 30 minutes. Patient left on her own.
No adverse affects. COVID 19 vaccine given > 12 hours form drawing. Vaccine was drawn, stored in refrigerator overnight. given to patient the following afternoon. Manufacturer notified. Awaiting guidance re. patient.
Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient experienced chickenpox. On an unspecified date, the patient recovered from chickenpox. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.