chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being thrown.  My head was thrown forward and I hit the counter hard and sustained a large contusion above my left eye.  The room was spinning and I was dizzy for the next few hours.  I never lost consciousness but had no control of my body for the few seconds of the episode.  The episode was sudden and violent and I was just sitting when it happened.   I spoke with my physician who diagnosed me with having experienced a Tumarkin otolithic crisis.  He has instructed me to wear a helmet and not to leave my home.  He is also recommending that I have a labyrinthectomy to treat the symptoms.  While I have a history of vertigo, I have not had any dizziness for more than a year.   I now feel dizzy on and off most of the day.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out a few minutes after receiving the shot, and hit his head when falling over. He quickly came about. First aid was provided. No sign of confusion.
I have had a dull headache ever since I received my first shot ..it has not gone away since 7/13/2021. Nothing I take makes it go away!also have had really bad leg cramps in both my legs, I go to bed with them and I wake up every morning with them.
pt recvd vax;approx 5 hrs later, rt lower area numbing,fingers swelling of rt hand;reported to hlth dept;
Thyroid Peroxidase (TPB) Antibodies came back high on bloodwork after the vaccine (never had antibodies on previous bloodwork)
The baby was crying non-stop for four hours and was inconsolable, no fever, vomited and possible seizure and took the baby to the hospital and was released after exam.
Patient has not experienced any adverse events.  Patient received a positive pregnancy test 25 days after receiving her second dose of Gardisil (HPV).
Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observed in car for 30 mins.  Pt endorsed similar reaction to initial vaccine
Pt developed a fever on 3/17. He received COVID test the same day which came back positive. His grandson who cares for him tested positive on 3/11 or 3/12.
ringing in left ear; she got extremely dizzy for 2 days; sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269, Expiration date: May2021), via an unspecified route on 18Feb2021 at 08:15 (at the age of 73-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included hyperthyroidism, low vitamin D. The patient concomitant medications included vitamin D 2400mg daily by mouth (Taken about 3 years, 2000mg tablet 400mg was gel cap, she takes 2 separate pills) for low vitamin D, methimazole 10mg one day tablet by mouth for hyperthyroid (Has taken for years). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation and experienced soreness in her arm. The patient experienced sore arm so she put a cold pack on it on 18Feb2021. After 3 days of getting the second shot of the covid vaccine she got extremely dizzy she could barely move for 2 days on 21Feb2021 and on the next day, the dizziness got better but she started getting had ringing in the ears on 22Feb2021. On the fifth day, the dizziness was there but she thought she could get up and try to walk. She reports she would not drive though, she was still dizzy. The dizziness drives her nuts. She doesn't feel sick to her stomach. Patient states she goes to an endocrinologist once a year for her blood work. She has hyperthyroidism. The outcome of the events sore arm was recovered on 19Feb2021, she got extremely dizzy for 2 days was recovering and ringing in left ear was not recovered.  No follow-up attempts are possible. No further information is expected.
I am breastfeeding. I am experiencing significantly leas breast milk production after second covid shot.
About 12 hours after getting my booster shot, I started having convulsions - uncontrollable spasms and shaking that made me really scared.  I went to bed and was able to fall asleep and the convulsions didn't come back, but it was something I had never encountered before.  I figured it would be good to report this so hopefully it can help others.  My other symptoms were normal and similar to after the second shot - fatigue, slight fever, and pain in the point of the injection.   This also makes me nervous about whether or not I should get booster shots in the future...
10-11-10 3 hours after receiving TIV, PPSV23 into LD c/o pain LD. 10-13-10 called on call triage nurse with c/o pain left arm, hot & cold flashes, did not have a thermometer to monitor temp, itches, arm so tender it hurts to pull (L) bra strap. 10-14-10 OV for pain LD, limited ROM/LA, taking Ibuprofen 800 TID & VICODIN without relief at home. Erythema from LD to elbow on anterolateral surface with streaking. VICODIN 5/500 & CEPHALEXIN 250 qid ordered. 10-14-10 OV symptoms much improved, no fever, ROM improved, swelling & redness improved.
Rec'd COVID booster shot from community provider; now reporting diarrhea since booster shot given ~3 weeks ago
Approximately 5 minutes after receiving vaccinations, patient became pale and diaphoretic. Patient stated that she was lightheaded and could not breathe. Pulse was weak with a rate 76 bpm. Blood pressure was 90/58. Patient was sweating profusely. C/O nausea and feeling like she was going to faint. Patient given cool cloths and observed by nursing staff until episode subsided. Vitals signs taken. She was observed for approximately 30 minutes. Patient stated she felt "much better" before leaving the health department.
This case was reported by a nurse via a sales representative and described the occurrence of generalized pain in a 11-year-old male subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) for prophylaxis.  On 25 July 2000, the subject had received his last diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine (DTaP vaccine).  On 24 July 2006, the subject received 1st dose of Boostrix (.lotAC52B009AA).  On 24 July 2006, "several hours" after vaccination with Boostrix, the subject experienced generalized aching, generalized pain, gastrointestinal upset, and at the time of initial reporting the outcome of the events were was unspecified.  The nurse was not sure that the subject's symptoms were caused by Boostrix; however, it was reported that the events were possibly related to vaccination with Boostrix.  Follow-up was received from the reporting nurse on 03 August 2006.  The nurse reported that at the time of immunization with Boostrix, the subject was "well" and that " there had been several cases of gastrointestinal virus with other patients in the office that day".  The subject had a history of asthma.  The events resolved on 25 July 2006.
After second injection on 6/3/2021, I felt fine. Upon waking on 6/4, I had a fever of 101, severe headache and body pain. On 6/5, I developed a 5? x 5? irritated red patch on my injection arm. On 6/6 I awoke to no fever. I then noticed sores in my mouth and busies on my abdomen, left leg and left foot. I went to urgent care. They ran a CBC. My platelet count was down 30% since ,my last test a few months ago. My average was about 180,000 for the last 6 years. My test number was 127,000.  I have no history of a low platelet count. This appeared within days of the 2nd vaccination along with the sores and spontaneous bruising. A CAT and v,MRI were performed that same day. Those tests were normal.
Received a dose of the Moderna Covid 19 vaccine that is past the 6 hour timeframe from being extracted from the vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine that is past the 6 hour timeframe from being extracted from the vial.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021 at 2:48 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine that is past the 6 hour timeframe from being extracted from the vial.). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine that is past the 6 hour timeframe from being extracted from the vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Patient complained of feeling shaky, cold, aches and pains, sweating, missed one day of work completely, taking TYLENOL.
Itching face and scalp, swelling and redness, eczema scaling on face and neck, swollen lips.
No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 06-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U024220, expiration date was reported as 03-AUG-2023 but upon internal validation established as 04-AUG-2023, 0.5 milliliter; strength and dose number were not reported) subcutaneously(SQ) for prophylaxis after temperature excursion (product storage error). The storage temperature of the vaccine was 10 degrees Fahrenheit (F) for a time frame of 14 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported.
When giving first administration in the left arm, syringe clicked several times and appeared to malfunction with early retraction of vanish point needle. The vaccine was seen running down the patient's arm with an amount that appeared to be more than half of the vaccine. Due to more than half of the vaccine not being administered correctly into the patient's arm, I discussed in detail the situation and options with the patient's mother. She was in full understanding and agreed that she wanted her daughter to be fully vaccinated, as it was confirmed by other bystanders that a large amount of the vaccine was on her arm/clothing. Following our protocol, a second full dose was administered in the opposite, right arm with verbal consent and understanding from the patient's mother.
Fever >101F beginning evening of vaccine, lasting 36 hours, responded to anti-inflammatory medication. Seeing spots during the night after vaccine. Sore/itchy feet on and off for 24 hours post vaccine.
Arm soreness (expected). Woke up twice in the night drenched in sweat (but didn't think to take temperature middle of the night). Woke up again around 7am and left side of neck (assuming lymph node) was very painful.  Hurt to swallow but not like strep throat, the lymph node hurt. Also hurt to touch neck.  Tongue appeared enlarged but breathing was normal.  Arm was never itchy. Tongue looked normal size a few hours later. Temperature was never elevated that I know of.  I had just gotten over a cold and got this vaccine after symptoms seemed to have cleared up.  Had gotten COVID-19 test, results were negative.
Extreme pain located in the vaccine administered right shoulder and also the right bicep, neck and back.  Contacted  my primary physician on  Wednesday January 26 and was given an an appointment for January 27, Thursday morning.   Examined by Dr, had Ultrasound on effected area and also blood drawn for testing.  Was provided notation for employer that I am to be off work until Tuesday February 1, 2022, possibly longer after test results and re-examination.
2" diameter 0;red, hard, tender rt leg upper thigh;temp;called ER:
very sick at the moment; she is coughing, very sick at the moment; I have a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick at the moment"; COUGH (non-serious), outcome "unknown", described as "she is coughing, very sick at the moment"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold". Additional information: The patient mentioned that she was scheduled today for the booster shot, for the second booster shot however she mentioned that she was coughing, very sick at the moment. The patient had a cold, she was coughing. The patient was sick she might have contracted a virus when she was in the hospital (Further not clarified). She didn't think it's appropriate for her to get a immunization shot. She would reschedule.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and pain redness at left arm. Itchy, gave Keflex, Benadryl, Motrin for Cellulitis Edema
Pt developed pain then redness and blisters at site of varicella vaccine consistent with shingles.
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml).    This case contains information about the 16th patient out of 27 patients as described by the reporter.  All the patients were over the age of 65 years.  No concomitant medications were reported.  The first booster dose of vaccine was administered in the deltoid site.  On 10-May-2023, 27 patients received 0.25 ml booster dose of the Moderna bivalent vaccine instead of 0.5 ml dose.  On 11-May-2023, 26 patients were contacted, and on 12-May-2023, 18 patients received an additional 0.25 ml booster dose, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25 ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be contacted by phone.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Fever after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after vaccination) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after vaccination). At the time of the report, PYREXIA (Fever after vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16-Apr-2021: Event outcome was updated. The patient told that she was doing fine.
I felt pain the arm where I got the first shot for a few days after getting it.  That eventually went away.  Then two or three weeks later, I started to have rapid heart rate without doing anything to cause that.  Usually, my heart beats fast when I exercise, drink coffee, or drink alcohol.  However, I did none of that and this symptom doesn't feel normal.  I went to urgent care to ask about it.  I told the doctor it must be side effect from the vaccine.  The doctor told me it was not.  I had blood work and was told that I was low in vitamin D.  After that, I took vitamin D and tried to exercise to see if it gets better.  After that, it got a little bit better.  But now, I'm feeling it has gotten worse.  I feel heavy in the chest.  My body doesn't feel right.
Within minutes of the vaccine my glands, neck, throat became swollen and sore. Pharmacist recommended taking Benadryl. Two hours later I felt better.
It was reported that a 19 y.o. female PT received a Menomune A/C/Y/W/-135 vax administered SC, at 6:30 p.m. on 9/18/01. 15 mins later the PT experienced itching on right arm and slight redness, given Benadryl 25 mg po, Blood pressure: 120/86, Pulse: 74. The PT left after a 20-min wait and agreed to watch for other Sx's of allergic reaction. PT "had a test" and left at 6:58 p.m. No shortness of breath, no hives or rash noted. The PT reportedly recovered.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. In approximately 2013 (reported as "about two years ago", the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided). On 09-NOV-2015 (also reported as today), the patient was vaccinated (as the second dose in series) with GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
RASH ON ANKLES, FEET AND LOWER LEGS; HIVES ON ANKLES,FEET AND LOWER LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced rash on ankles, feet and lower legs, and hives on ankles, feet and lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on ankles,feet and lower legs, and rash on ankles, feet and lower legs. This report was non-serious.
Client presented to the vaccination site on 12/27/2021. The client notified RN that he received the 2nd dose of Pfizer COVID 19 vaccine on 06/28/2021 and is requesting a Pfizer booster to be given one day prior to booster eligibility. Pfizer booster eligible for 12/28/2021. Per patient needs booster to be allowed in the operating room for the arrival of his baby girl. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer booster. Per CDC guidance, approval to proceed with COVID vaccine Pfizer was obtained from medical consult team via text message from MD, Vaccine Operations Lead . Client received COVID vaccine Pfizer Lot#  FL3197 on 12/27/2021. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 5:05pm with a steady gait. VAERS and VERP completed.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 24 July 2006 the subject received 5th dose of Infanrix, intramuscularly, in the left thigh (lot AC14B033AA). On 24 July 2006, the subject also received measles, mumps and rubella vaccine, strain not specified (MMR II, Merck) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) at an unspecified site of injection. On 25 July 2006, 1 day after vaccination with Infanrix, the subject experienced injection site cellulitis, injection site redness, injection site warmth and swelling injection site. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). The events resolved on an unspecified date on or after 25 July 2006 and on or before 17 August 2006. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 05 September 2006 indicated that the events did completely resolved and were related to treatment with Infanrix.
fever- 100, headache, congestion, body aches. starting on 8/29/21