chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Td and TB skin test on 08/22/2005, on 08/23/2005 awoke with left arm red, hot and swollen and was running fever. Seen by health dept doctor, Continued warm soaks and Tylenol on 08/24/2005, arm still red hot and swollen, 08/25/2005 symptoms continued including fever.
Patient states when she took her 3rd dose, she developed hives.  She visited her primary care physician.
Patient received three vaccines on 09/15/20. He got Shinrix in right arm and Fkuzone HD and Boostrix in the left arm. Patient has a rash around the area which he scratched and and broke the skin so there are exposed areas and he has a bump rising up from from the broken skin area. He stated that some liquid was coming out of the bump. Patient went today 11/20/20 to physician and received Keflex and Bactroban ointment.
The patient received the GARDASIL 9 vaccine on 12/17/18 instead of the TDaP she was supposed to receive. She is 30 weeks pregnant with EDD 2/17/2019. Upon the MA realizing what happened, she notified the physician. The physician contacted the patient and no adverse reaction occurred with the patient.
I never had any issues with the joints and muscles in my hands, fingers and wrists. The night of the vaccine my hands were so achy and uncomfortable it woke me up in my sleep and continued with extreme discomfort for about 3 more days.  My hands are still achy and uncomfortable on a daily basis. I never experienced this before the vaccination.  I have to massage them and take ibuprofen to get relief.
I walked into pharmacy to receive my flu vaccine. Filled out the consent form and only placed that I wanted to receive the flu vaccine. The pharmacist took me into the back room and gave me a shot. After the shot was administered the pharmacist realized he had given the Pfizer booster instead of the flu shot.
11AUG98 solid red area on lt upper arm non-raised;hot to touch;12AUG98 red circular rash-nl;skin color in middle;rash appeared 5 days p/vax;
6/28 25y.o. G1P0 at 38w5d by L=8wk US who c/o pressure and ctx since this morning 6/28 SVD.
Difficulty waking-up, irritability and depression persistent until about 1 pm. Following day woke-up with rash on torso, arms, neck.
Received 2nd of 2 doses of SHINGRIX vaccine at 10am. Had pain in the upper arm in the afternoon where the shot was applied. At about 9pm, experienced severe chills. Lay in bed with heavy quilt. Vaccine was administered at pharmacy. Detailed charges from receipt: GSK SHINGRIX 0/5 mL Recombinant IM; without preservative. Immunization admin, 1 single/comb Vac/Toxoid, mod INS. First dosage was administered on May 9, 2018. Had no arm pain or other reaction to first injection. Have had many travel vaccines notably without reaction.
On 04/12/21 I had just eaten and sat down at the computer. I started feeling disoriented, light headed and my vision started to become affected. I could not focus my vision and tried to vomit also also but immediately went to bed. Throughout the day/night when i got up I was unable to walk/see as normal and required my hand on the wall for balance. I also felt nauseated and could not eat anything during this time. I was able to sleep mostly and as of this submittal(04/13/21 7:51 pm CT) i have been symptom free for several hours. No medical treatment was sought due to no health insurance. All symptoms indicate stroke .
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 18-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature of 1 F. There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1F and 0 F, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report refers to a male patient of unknown age with heart issues/problems. Drug reactions/allergies included penicillin and "calflex". On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and dose not provided). Concomitant medication included unspecified treatment for heart problems. On an unspecified date 10 months ago (estimated as December 2012) patient experienced an injection-site reaction. It has spread and been consistent. The rash was mainly red, rough dry spots appearing all over his body from his neck to his toes. While the rash was very itchy, the patient had no pain. The spots came and go. Patient had used 4 unspecified creams prescribed by a dermatologist, however, they only got rid of the spots briefly before new ones showed. Yesterday (estimated as 06-OCT-2013) patient developed a rash all over the upper part of his body that was very red. Patient "just" (estimated as an unspecified date in 2013) got the flu shot. Other suspect therapies included influenza virus vaccine (Manufacturer unknown). The outcome of itchy, rash all over and injection site reaction was reported as not recovered/not resolved. Additional information has been requested.
brain fog; sore arm; mild queasiness; diarrhea; cold sores on lips; This is a spontaneous report from a contactable consumer (patient). An 83-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 25Jan2021 15:45 (Lot number was not reported) as single dose (at age of 83-year-old) for covid-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), high blood pressure, allergies to shellfish. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 26Jan2021 10:00 patient experienced Sore arm, mild queasiness and diarrhea, brain fog, and cold sores on lips. No treatment was received. Patient was recovering from the events, at the time of the report.  The batch/lot number number is not available despite the follow-up attempts made.
8 days after vaccine was administered, the patient developed redness, swelling, warmth and hardness at the injection site. The redness is about the size of a fist. Person encouraged to seek treatment with their PCP or urgent care.
Onsite pharmacy delivered Flubok to a Pediatrics location in error.  Pediatric staff administered Flublok.
STOMACH ACHE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 2021, the subject experienced stomach ache. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, and headache on 2021. This report was non-serious.
Exactly one week after the vaccine, I awoke to feel the injection site very itchy and hot.  When I looked, it was swollen around the injection area...previously no irritation at all.  At the same time, I felt like I was catching a head cold:  lots of postnasal drip and some coughing and general tiredness.  Injection site symptoms lasted about 24 hours.  Cold like symptoms lasted 3 days.
pt recvd vax for prophylaxis; 23 days later exp Bell's Palsy, a rash behind knees & on hands which blistered, v, fever, ha,aches, pain across shoulders & a boil in rt inguinal area; unresolved;
Information has been received from a registered nurse concerning a 17 year old female with no known drug allergies who in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. In February 2007, "shortly after" vaccination, the patient developed fever, chills and flu-like symptoms. The patient was treated with acetaminophen (TYLENOL). On an unspecified date, the patient recovered from the fever, chills and flu-like symptoms. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007. Follow-up information was received from the registered nurse stating that they had no additional information on the case.
On February 18th, a week after I got my vaccine, I noticed swelling in upper left arm with a red rash that felt hot and was quite itchy.  It spread from the shoulder down into the elbow within a couple of days.  I treated with Benadryl cream initially  and Cortisone 10 after Benadryl didn't seem to help much.  Not sure it helped either.  Swelling and redness began decreasing after about a week, but itch remained until today (March 3rd).  As the itch decreased, it felt like it occurred in spots, as though it was moving.  I feel as though the worst is over, but still experience an occasional itch in various locations of the upper left arm.  I also had a slight headache the day after the vaccine was administered.
After I got the vaccine, I had a sore arm for about a day. In March my finger was very irritated it felt like it was on fire. My finger then started becoming numb and started changing colors. I also had Covid in 2020. I had a foot drop and my right feet; I couldn't lift my toes on my right foot.
Diffuse 5-7mm reddish blanching macular rash over trunk 12 days post vaccine.
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches,
Vomited 13 times in a 12-hour period. 9:30am, 9:57am, 10:23am, 10:45am, 11:00am, 11:25am, 11:46am, 12:08pm, 12:46pm, 1:26pm, 2:38pm, 3:48pm and 6:14pm.
Extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 01May2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mango. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 16:00, the patient experienced extreme dizziness. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme dizziness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient developed raised, blistering hives all over body and profuse itching all over.  She used Bactroban thinking it may help but no improvement. Saw physician on 10/07/16 where he prescribed Prednisone and Hydroxyzine.
This case was reported by a nurse via call center representative and described the occurrence of syncope in a 18-year-old patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). This case was associated with a product complaint. In July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In July 2016, 5 min after receiving BEXSERO, the patient experienced syncope (serious criteria disability), nausea (serious criteria disability), fever (serious criteria disability), injection site erythema (serious criteria disability), injection site rash (serious criteria disability), injection site pain (serious criteria disability), and injection site swelling (serious criteria disability). On an unknown date, the patient experienced pharmaceutical product complaint. BEXSERO was discontinued. On an unknown date, the outcome of the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the syncope, nausea, fever, injection site erythema, injection site rash, injection site pain and injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccinations for the patients were not reported. The registered nurse reported to the sales representative that she had 10 single packaged doses of BEXSERO with the same lot number and 8 doses were administered to the patients. Out of the 8 patients who received the vaccine, 6 patients (3 female, 2 male, 1 unknown), approximately 18 years of age, experienced a range of side effects including syncope, fever (greater than 101 degrees F), nausea and injection site reactions including erythema (size of a silver dollar), swelling, redness, rash and pain. One female patient experienced syncope 5 minutes after vaccination with BEXSERO. This patient had also experienced syncope after vaccination with GARDASIL in the past. Limited information was provided by the sales representative from the nurse, as the nurse did not have the patients charts and was unable to provide specific information about the events experienced by the patients. The nurse believed there was something wrong with the lot number. The nurse refused to use the last two doses and wanted the product to be tested. If something was found wrong with the vaccine, then she requested credit for the two remaining doses and she would return the product. The nurse reported to sales representative that the vaccine was kept in the refrigerator, not frozen and nothing unusual was noted about the product or packaging. The nurse also informed that an entire dose was administered to each patient.
Sore injection sight for 3 days. Heart Palpitations started on 1/1/2021. Increased Blood Pressure (prior to vaccine maintained after vaccine my bp increased to 124/97 on Jan 5 and by Jan 6 it was 157/112 pulse 143. Shortness of breath, dizziness, difficulty with breathing after exertion, increased joint pain and muscle weakness.
she developed rashes all over the face and neck; This is a spontaneous report from a Regulatory Authority. From a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after a few hours when she left the facility (after 1st shot), she developed rashes all over the face and neck on an unspecified date in Mar2021 with outcome of unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission /patient expired after 2 vaccines Pfizer 4/1/21 lot# Ew0150;  Pfizer 5/12/21 lot# Ew0158
Initial and follow up information has been received from a physician, regarding a 25 year old caucasian female patient, and editor, with no known drug allergies, who on 07-DEC-2007 at 4:30 pm, was vaccinated IM in the left deltoid, with the second dose, 0.5 ml, of Gardasil (lot #655322/1211U).  There were no side effects associated with the first dose of Gardasil (date not specified).  There was no illness at the time of vaccination.  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On approximately 27-DEC-2008, the patient called the physician's office and stated that post vaccination, her left arm had been sore, but it had gotten better (duration not specified).  She added though, that on approximately 20-DEC-2007, her arm had become sore again.  The patient also reported weakness in her arm.  There was no redness or fever.  Treatment with MOTRIN was recommended by the physician.  On 10-JAN-2008, the patient called the physician back with complaints of continued pain in her arm, described as pain when she lifted her arm over her head and when she lay on her side on the arm.  At the time of this report, the symptoms continued, but had lessened.  The physician considered arm sore again with weakness to be persistent or significantly disabling or incapacitating.  Additional information has been requested.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning a 34-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 09-Jan-2012, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Developed numbness in feet and legs a few hours after flumist vaccine. Low grade temp for one day (10/12/13).  On 10/13/13 had altered mental state,was confused and dizzy, couldn't bear weight and fell.  Admited to Hospital.  LP results consistent with aseptic meningitis/encephalitis.  CT of head showed no intracranial abnormality.  Mental status returned to normal and was discharged on 10/16/13.
4 days after vaccination (01/15/2021) client stated she was having armpit soreness without swollen lymph nodes.  This morning (01/20/2021) when she woke up she had a 1 inch red circle around injection site, swollen and warm to touch.  Advised client to seek medical care either by PCP or Urgent Care.
Per client: Noted pain immediately upon receiving vaccine-continues to present, wanes at times but recurs. Pain occasionally travels from upper arm to lower arm. Pain varied beginning with stabbing, sharp pain, now more achy. Treated with Excedrin briefly with little result. No swelling. Saw doctor 12/20/06 for routine physical.
Info regarding Prevnar vaccine was received from a healthcare professional regarding a pt who experienced injection site swelling and injection site knot. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included unspecified vaccines. EVENT DETAILS: The reporter stated that one or two pts developed knotted swelling at the injection site and injection site induration. This is one of two reports from this facility where a pt developed knotted swelling following receipt of Prevnar. No additional info was available at the time of this report.
Expired vaccine was injected into the patient. A vial was punctured on 7/2/21 at 1:35pm Central time and kept in proper refrigeration temperatures. Instead of the vial being thrown out after the six hour viability window per the manufacturer, it was used on 7/3/21 and a single dose was injected into the patient. Janssen was contacted after the error was discovered and they could give no guidance as to a course of action to take. There was no recommendation on if the patient should be revaccinated or not. The patient will be contacted regarding the information gathered. No adverse event has been reported from the patient as of yet.
Person administering hit a vein and blood was dripping down.  Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.
injection site rash; numerous red blemishes on body; body ache; headache; Back ache; Canker sores; Tooth pain; Sore throat; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (received 1st dose on 30th August 2019 and experienced Numerous red blemishes on body body aches head ache back ache canker sores tooth pain sore throat chills).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills were unknown.   It was unknown if the reporter considered the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe reaction, rash at injection site, numerous red blemished on body, body aches, headache, backache, canker sore, tooth pain and sore throat chills. It was unknown if the reporter consented to follow up.
seen by MD 30NOV95 w/cellulitis rt arm-warm compresses & ATB ordered
Shaking spells, development of tremor, headache, cognitive difficulty. Complaints of daily HA, frequent seizures, development of head and hand tremor and memory problems.
General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Flulaval Quadrivalent given nasal, not intramuscular. Wrong route.