chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to  to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot.  The site were I had to shot was  burning like it had been branded.  I had brain fog couldn't remember what i was doing up.  Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area.  the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch.  Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.
experiencing bilateral lung blood clots; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was experiencing bilateral lung blood clots (medically significant) in 2021 with outcome of unknown.    Information on the batch/lot number has been requested.; Sender's Comments: Based on description given in the narrative, there is reasonable possibility of causal association between the event Pulmonary thrombosis and the suspect BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
severe chills, T101, treated w/motrin, felt weak & limp;better next day;
Hepatitis A, adult dose given to 14 yr old when Hepatitis A pediatric dose should have been given. Med error.
After the shot, I felt okay.  in the evening after dinner, I did a routing excise using 5lb weights using both arms.  in the later evening my left side of ear felt uncomfortable.  The second morning, my left side back was painful, but not so bad.  but in the night, it waked me up with burning pain on my back, and burning pain in my  esophagus all the way to my throat.  I never had this in my life before.  I feel my whole up body(left) was on fire.  I took some tums, and Prilosec again, did message on my back.  it?s getting better next day.  and I went to see my acupuncture doctor, GI doctor.  the symptom is still there.  today, I feel my left side arm, hand and foot numbness.  I was very worried now.
The patient said that she woke up out of her sleep with chills. No matter how many blankets she use she was still cold. She had a temp of 102.4. She Threw up many times. She was sick like this for a day and a half. She was experiencing extremer fatigue and then it went away.
Patient reports dull ache in his arm that radiates down to his hand. It has improved over time but is still sore and a little weak.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2014, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a physician.  On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Red rash around mouth; Inside lips numb; Tip of tongue sensitive; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 12:00 (at the age of 63-years-old) as a single dose for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Right on 14Feb2021 12:00 (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) in two weeks included diltiazem hcl; atorvastatin calcium. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021, the patient experienced red rash around mouth. Inside lips numb. Tip of tongue sensitive. Happened about 5 days after first vaccine, and lasted for a couple of weeks. Then again after second vaccine, 5 days after. Outcome of the event was not recovered, at the time of this report.
her husband experienced shingles in November- December of 2022; 1st dose Oct2020, 2nd Jan2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 2nd dose of Shingrix. In OCT-2020, the patient received the 1st dose of Shingrix. In JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Oct2020, 2nd Jan2023). On an unknown date, the patient experienced shingles (Verbatim: her husband experienced shingles in November- December of 2022). The outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2023 The reporter was patient's wife. The patient received Shingrix dose 1 around October 2020.  The patient experienced shingles in November - December of 2022.  The reporter did not want to provide any additional information. The reporter did not consent to follow-up.  The patient had received the second dose of Shingrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule. This case was linked with US2023033407, reported by same reporter.; Sender's Comments:  US-GSK-US2023033407:Same reporter adn differnt patient
I was sore the first day on 02/08/2021 after getting the vaccine and by  second day 02/09/2021 I got up that morning and I wasn't feeling good. I was queasy and I tried to eat something and around 5 PM I started vomiting and had diarrhea and it became intractable. I went to the ER 02/09/2021 at night time (unsure of time) and they gave me fluids and nausea medicine. They did blood work ( CMP, CBC, Urine, Chemistries', Thyroid) and the Dr. said since I had covid and the both of the vaccines that I was possibly having a hyperactive immune response. I did see my PCP to establish care (unsure of date but it was a few weeks after ER visit) and she did a follow-up since my ER visit, and she said I could have hyperthyroidism. I will be seeing an endocrinologist soon.
NASAL CONGESTION; SWEATING; FEVER; MODERATE HEADACHE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy, sleep apnea, high blood pressure, chronic fatigue, nonsmoker, nonalcohol, and muscle spasms.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included baclofen for drug used for unknown indication, hydrocodone bitartrate/paracetamol for drug used for unknown indication, ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc for nasal congestion, loratadine for nasal congestion, and modafinil. On APR-2021, treatment medications included: ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced nasal congestion. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced moderate headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nasal congestion, fever, moderate headache, and sweating. This report was non-serious.
Arm was red "knotty" from shoulder to elbow. Resolved with BENADRYL over 48-72 hr.
My periods have been about 3-4 days longer than before. My cramps have amped up so much that medication doesn't do a dent in them. I have to take Acetaminophen stacked with ibuprofen while using a heating pad. I never had menstrual migraines prior to the vaccination and now I have migraines 3-4 times a month. These migraines are lasting from 1-2 days at a time, which has also forced me to miss work when I have them. 06/16/2021 I visited Dr. and he put me on Naproxen for my migraines. He stated I needed to visit a OB/GYN for the menstrual cramping. I have yet to visit one.
Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.
Myalgia, CoughWheeze, NauseaVomiting, hot flashes Narrative:  Myalgia, nausea, cough, hot flashes -  "waves of heat"  Other Relevant History:
Developed hives on face and back within 10 minuters of vaccine administration. Patient remained alert and talkative.  No respiratory symptoms.  Hives diminished within 20 minutes. No other symptoms or complaints.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. From 25-OCT-2017 through 07-NOV-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The temperature involved was 35 degrees Fahrenheit for 16 hours. There was no previous temperature reported, and a data logger was not involved. Sender's Comments: US-009507513-1711USA003934: Original Case: 1711USA003934; US-009507513-1711USA010361: Original Case: 1711USA003934.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot # unknown) 0.5 mL injection. After receiving Gardasil the patient experienced swelling from injection site down the length of arm. Medical attention was sought. On an unspecified date the patient recovered. No further information was provided. Additional information has been requested.
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture's guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
BLURRED VISION; SWOLLEN LIPS; BURNING LIPS; This spontaneous report received from a patient concerned a 91 year old female. 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: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced blurred vision. On 11-MAR-2021, the subject experienced swollen lips. On 11-MAR-2021, the subject experienced burning lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, swollen lips, and burning lips. This report was non-serious.
mom reports 8OCT92 that p/last set of immun 30JUL92, pt cried uncontrollably & inconsolably for 3 days; pt also had shakes for 2 days p/the vax;
After Taking one tab of oral typhoid vaccine (Vivotif), at 8am on 3/30/06 Patient noticed at 10:30am a single erythemic papule. By noon arms, neck, palms, wrists had erythemic plaques.  Patient went to ER.  She was given IV Benadryl, PO predisone and one tab Pepsid. Symptoms resolved. Took PO Benadryl and Prednisone at 8:30 am 5/1/06.  By 11am rash had reappeared on dorsal aspect of palms and inner aspect of feet.  Patient took an additional 50 mg of Benadryl and came to the clinic and which time she was evaluated and given 20 mg of prednisone, continue with 40 mg prednisone x 4 days.  To take Benadryl prn and Allegra 180 mg po qd.  Patient exhibited no anaphylaxis.
Patient returned to clinic stating that she felt like her throat was swollen and she was having trouble swallowing.  She had redness along face, chest and right upper arm. Patient evaluated by provider and Epipen administered at 9:54 AM.  Patient was observed for 1 hour and released to home with Epipens and instructions on how and when to use them.
Achy; Fatigued; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, approximately 1 week after administration of first dose of vaccine, the patient was achy and fatigued. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pat states had dyskinesia the affected areas mentioned were both arms/hands & chest, onset 2hrs after vac. also "swelling on stomach" & stiffness.
Severe burning sensation when vaccine administered.  Started having a deep ache in the arm that night, radiated from the shoulder to the elbow.  Lasted several days.  Have had pain intermittently since, worse yesterday and today.  Very sore to the touch.  Painful if moved certain ways.
More than normal pain was experiences as the vaccine was being administered. About four hours after injection, extreme pain in left shoulder, rotator cuff, unable to move arm .  Had to take ibuprofen approximately every six hours for the next 24 hours.  Two days since the injection, the pain is about 20 percent less.  NOTE 1: The probable reason for the unusual pain was that the injection was given much too high on the arm, near the top of the shoulder. I went back to the pharmacy on March 6, 2021, spoke with senior pharmacist, and showed the injection location with the band-aid still on. He noted it was a "bit high" and who had administered the vaccine. He said he would look into the injection technique of the person who had administered the dose.  NOTE 2 - THIS IS THE REASON I SUBMIT THIS REPORT: While the situation is handled at the pharmacy in question, I believe that with the rush to get the vaccine into arms, the CDC may need to pay more attention to the experience level of those administering it, making sure they have the proper training and actually have learned the proper injection technique. The CDC's YouTube video I have seen on the injection technique is a bit long.  The segment beginning at the 2:40 minute point should be separated and labeled "injection technique for adults" and have it made clearer that the injection is at the CENTER of the deltoid, with the very top of the inverted triangle NOT being acceptable.  My understanding is that the pain level from injecting at the rotator cuff is unnecessary and can lead to SIRVA - "Shoulder Injury from Vaccine." Please take the necessary steps to ensure the vaccine is being properly administered at the correct place in the arm. Otherwise, too many people will be undergoing unnecessary,  extreme pain as I have .
Red itchy rash like a large hive that is sore to touch like a bruise and warm to the touch. The rash started as a small red mark right where the injection was and then grew throughout the day.
I was vaccinated for my 2nd dose of Moderna Vaccine on 5/4/21. We have been trying to get pregnant for months and I found out on 5/14/21 that I was pregnant. Confirmed with a hcg blood test at the urgent care on 5/15/21. Monday 5/17/21 at around noon, I just started spotting and went to MD right away. He ordered bedrest for the whole week but my bleeding didnt stopped and led to miscarriage.
Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.
Pt vaccinated with DTP/OPV/HIB mother reported uncontrollable crying started about 2 hrs after vaccine and continued for 3 to 3 1/2 hrs. temp 99 (A). Phoned MD gave Tylenol.
Follow up on 11/13/2003: "Rash started as red dot on left hand, progressed to right forearm was itchy.  Prescribed Benadryl/Prednisone/resolved 1 week.
Case number PHEH2014US014081, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error.
pt brought to hospital with increasing confusion; had recently been dc'd to a nursing home (no record of the name in medical records) after being treated for COVID pneumonia; admitted to ICU with septic shock; given ABX, fluids; O2; DNR; poor prognosis; pt developed  PEA; family requested no treatment; and pt passed away in the hospital
Mild fever; Swollen Lymph node under armpit on the same arm as injection site; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included multi vitamins (MANAFACTURER UNKNOWN), birth control (MANAFACTURER UNKNOWN) all from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00 the patient experienced mild fever, swollen lymph node under armpit on the same arm as injection site. The clinical outcome of the events fever, swollen lymph nodes was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Day 1- Dizzyness, over the following weeks, developed ear fullness,, tinnitus, extreme vertigo (immobile), exercise induced migraine .  Symptoms continue.
a friend had the booster with blood thinners and it caused her heart to go fast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  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 included: "Blood thinner" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "a friend had the booster with blood thinners and it caused her heart to go fast". Relevant laboratory tests and procedures are available in the appropriate section.  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.
Headache that progressed over several weeks to become severe headaches unrelieved by medication. Then tremor, rapid heart rate, weakness, fatigue, and insomnia have persisted ever since being vaccinated.
About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. At the same time, my injection arm started burning.  Also, I started experience a mild headache while on the way home which became VERY bad about an hour after the vaccination (at home).  My head, neck and shoulders hurt so badly that I could not move and my vision was blurry; it was a searing type of pain.  Then, I developed a fever which, at its highest temperature, was 101.6° along with overall achiness, malaise and severe fatigue,
The onset of pain occurred almost immediately, the pain worsened and continued in the following days. The pain was a burning, aching and throbbing sensation that took over my left shoulder. As the days progressed my range of motion and strength in my left arm was severely limited. It became difficult to put on clothes and sleep on my left side. I saw my PCP and was given Celebrex, I went to a chiropractor for soft tissue laser treatments to reduce the pain and inflammation. I was admitted to Hospital on March 9,2019 due to a total loss of function on my left arm and extreme pain from my shoulder down to my left hand and across the left side of my chest. I was prescribed steriods.
Left thigh marked local reaction with swelling, redness and soreness covering almost the whole thigh. Treatment with prednisolone 15/5/mg/kg/d x 5 days / local HC D/O cream PRN